| Product Description |
Code Info |
Classification |
Reason for Recall |
Product Quantity |
Recall Number |
| Products: .5-1mm 2cc Cancellous Chips; .5-1mm 15cc Cancellous Chips; .5-1mm 30cc Cancellous Chips.
Cancellous Chips. Product s are labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID:
NLGIN09-0024C
NLGIN10-0004
NLGIN10-0005
NLGIN10-0009
NLGIN10-0012
NLGIN10-0016
NLGIN10-0018
NLGIN10-0020
NLGIN10-0024
NLGIN10-0033
|
Tissue ID #:
AI090024C2013, AI090024C2014, AI090024C2015, AI090024C2016, AI090024C2017, AI090024C2018, AI1000042016, AI1000052013, AI1000052014, AI1000052015, AI1000052016, AI1000052017, AI1000092019, AI1000092020, AI1000122013, AI1000122014, AI1000122015, AI1000122016, AI1000122017, AI1000122018, AI1000122019, AI1000122020, AI1000122021, AI1000122022, AI1000162019, AI1000182005, AI1000202018, AI1000202019, AI1000202020, AI1000202021, AI1000242009, AI1000242010, AI1000242011, AI10110402005, AI10110402006, AI10110402007, AI10110402008 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
37 Tissues |
B-2227-12 |
| Product: .25-.5mm 15cc Cancellous Chips.
Cancellous Chips Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" .
Donor ID # - NLGIN10-0016.
|
Tissue ID #:
AI1000162018
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
1 Tissue |
B-2228-12 |
| Products: 1-4mm 5cc Cancellous Chips; 1-4mm 10cc Cancellous Chips; 1-4mm 15cc Cancellous Chips; 1-4mm 30cc Cancellous Chips; 1-4mm 40cc Cancellous Chips; 1-4mm 60cc Cancellous Chips.
Cancellous Chips Products are labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID#:
NLGIN09-0024C
NLGIN10-0001
NLGIN10-0004
NLGIN10-0005
NLGIN10-0007
NLGIN10-0009
NLGIN10-0012
NLGIN10-0013
NLGIN10-0016
NLGIN10-0018
NLGIN10-0020
NLGIN10-0021
NLGIN10-0024
NLGIN10-0025
NLGIN10-0031
NLGIN10-0033
NLGIN10-0038
NLGIN10-0040
NLGIN10-0047
NLGIN10-0052
NLGIN10-0066
NLGIN10-0069
NLGIN10-0076
NLGIN11-0014
NLGIN11-0051
|
Tissue ID:
AI090024C2009, AI090024C2010, AI090024C2011, AI090024C2012, AI1000012005, AI1000012006, AI1000012007, AI1000012010, AI1000012011, AI1000042011, AI1000042012, AI1000042013, AI1000042014, AI1000042015, AI1000052010, AI1000052011, AI1000052012, AI1000072006, AI1000072007, AI1000072008, AI1000072009, AI1000072010, AI1000072011, AI1000092014, AI1000092015, AI1000092016, AI1000092017, AI1000092018, AI1000122010, AI1000122011, AI1000122012, AI1000132005, AI1000132006, AI1000132007, AI1000162020, AI1000162021, AI1000162022, AI1000162023, AI1000162024, AI1000182006, AI1000202005, AI1000202006, AI1000202007, AI1000202008, AI1000202009, AI1000202010, AI1000202022, AI1000202023, AI1000212014, AI1000212015, AI1000212016, AI1000212017, AI1000212018, AI1000212019, AI1000242006, AI1000242007, AI1000242008, AI1000252008, AI1000252009, AI1000252010, AI1000252011, AI1000312005, AI1000312006, AI1000312007, AI1000312008, AI1000382005, AI1000382006, AI1000382007, AI1000382008, AI1000382009, AI1000402005, AI1000402006, AI1000402007, AI1000402009, AI1000402010, AI1000402011, AI1000402012, AI1000472005, AI1000472006, AI1000472007, AI1000662005, AI1000662006, AI10110032005, AI10110032006, AI10110032007, AI10110172006, AI10110172007, AI10110172008, AI10110402010, AI10110402011, AI10110402012, AI10110402013, AI10110402014, AI10110402015, AI10110402016, AI11010032005, AI11010032006, AI11030032005, AI11030032006, AI11030032007, AI11030032008, AI11060012010, AI11060012011, AI11060012012 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
104 Tissues |
B-2229-12 |
| Products: 4-10mm 15cc Cancellous Chips; 4-10mm 30cc Cancellous Chips, 4-10mm 40cc Cancellous Chips, 4-10mm 60cc Cancellous Chips.
Products are labeled in part: Cancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN09-0024C
NLGIN10-0001
NLGIN10-0004
NLGIN10-0005
NLGIN10-0007
NLGIN10-0009
NLGIN10-0012
NLGIN10-0013
NLGIN10-0016
NLGIN10-0020
NLGIN10-0021
NLGIN10-0024
NLGIN10-0025
NLGIN10-0033
NLGIN10-0047
NLGIN10-0052
NLGIN10-0066
|
Tissue ID #:
AI090024C2005, AI090024C2006, AI090024C2007, AI090024C2008, AI1000012008, AI1000012009, AI1000042005, AI1000042006, AI1000042007, AI1000042008, AI1000042009, AI1000042010, AI1000052005, AI1000052006, AI1000052007, AI1000052008, AI1000052009, AI1000072005, AI1000092005, AI1000092006, AI1000092007, AI1000092008, AI1000092009, AI1000092010, AI1000092011, AI1000092012, AI1000092013, AI1000122005, AI1000122006, AI1000122007, AI1000122008, AI1000122009, AI1000132008, AI1000132009, AI1000162005, AI1000162006, AI1000162007, AI1000162008, AI1000162009, AI1000162010, AI1000162011, AI1000162012, AI1000162013, AI1000162014, AI1000162015, AI1000162016, AI1000162017, AI1000202011, AI1000202012, AI1000202013, AI1000212005, AI1000212006, AI1000212007, AI1000212008, AI1000212009, AI1000212010, AI1000212011, AI1000212012, AI1000212013, AI1000242005, AI1000252005, AI1000252006, AI1000252007, AI1000472009, AI1000472010, AI1000472011, AI1000472012, AI1000472013, AI1000472014, AI1000472015, AI1000662007, AI1000662008, AI1000662009, AI10110172009, AI10110172010, AI10110172011, AI10110402017 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
77 Tissues |
B-2230-12 |
| Products: .5-1mm 1cc Cortical Cancellous Chips, .5-1mm 2cc Cortical Cancellous Chips.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0013
NLGIN10-0024
NLGIN10-0025
NLGIN10-0035
NLGIN10-0038
NLGIN10-0066
|
Tissue ID#:
AI1000130505, AI1000130506, AI1000130507, AI1000130508, AI1000130516, AI1000130517, AI1000130518, AI1000130519, AI1000240509, AI1000240510, AI1000240511, AI1000240512, AI1000240513, AI1000240514, AI1000240515, AI1000240516, AI1000240517, AI1000240518, AI1000240519, AI1000240521, AI1000240522, AI1000240523, AI1000240524, AI1000240525, AI1000240526, AI1000240528, AI1000240529, AI1000240530, AI1000240531, AI1000240532, AI1000240533, AI1000240534, AI1000240535, AI1000240536, AI1000240537, AI1000240539, AI1000240540, AI1000240544, AI1000240545, AI1000250524, AI1000250525, AI1000250526, AI1000250527, AI1000250528, AI1000250529, AI1000350535, AI1000350536, AI1000350537, AI1000350538, AI1000350539, AI1000350552, AI1000350553, AI1000350554, AI1000350555, AI1000350556, AI1000350557, AI1000350558, AI1000350559, AI1000350560, AI1000350561, AI1000380506, AI1000380507, AI1000380508, AI1000380509, AI1000380510, AI1000380511, AI1000380512, AI1000380513, AI1000380515, AI1000380516, AI1000660505, AI1000660506, AI1000660507, AI1000660508, AI1000660509, AI1000660510, AI1000660511, AI1000660512, AI1000660513, AI1000660514, AI1000660515, AI1000660516, AI1000660517, AI1000660518, AI1000660519, AI1000660520, AI1000660521, AI1000660522, AI1000660523, AI1000660524, AI1000660525, AI1000660526, AI1000660527, AI1000660528, AI1000660529, AI1000660530, AI1000660531, AI1000660532, AI1000660533, AI1000660534, AI1000660535 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
101 Tissues |
B-2231-12 |
| Products: 1-2mm 1cc Cortical Cancellous Chips, 1-2mm 2cc Cortical Cancellous Chips,1-2mm 5cc Cortical Cancellous Chips.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0020
NLGIN10-0031
NLGIN10-0035
NLGIN10-0038
NLGIN10-0047
|
Tissue ID #:
AI1000200536, AI1000200537, AI1000200538, AI1000200539, AI1000200540, AI1000310510, AI1000350505, AI1000350506, AI1000350507, AI1000350508, AI1000350509, AI1000350510, AI1000350511, AI1000350512, AI1000350513, AI1000350514, AI1000350515, AI1000350516, AI1000350517, AI1000350518, AI1000350519, AI1000350520, AI1000350521, AI1000350522, AI1000350523, AI1000350524, AI1000350525, AI1000350526, AI1000380518, AI1000380519, AI1000380520, AI1000380521, AI1000380522, AI1000380523, AI1000380525, AI1000380526, AI1000380527, AI1000380528, AI1000380529, AI1000380530, AI1000380531, AI1000380532, AI1000380533, AI1000380534, AI1000380535, AI1000380536, AI1000380537, AI1000380538, AI1000380539, AI1000380543, AI1000380544, AI1000380545, AI1000380546, AI1000380547, AI1000380549, AI1000380550, AI1000380552, AI1000380554, AI1000470508, AI1000470509, AI1000470510, AI1000470511, AI1000470512, AI1000470513, AI1000470514, AI1000470515, AI1000470516, AI1000470517 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
68 units |
B-2232-12 |
| Products: 100mm Femur Shaft
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0038
NLGIN10-0047
|
Tissue ID #:
AI1000380105, AI1000380106, AI1000470105, AI1000470106
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
4 Tissues |
B-2233-12 |
| Products: 150mm Femur Shaft.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0047
|
Tissue ID #:
AI1000470107
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
1 Tissue |
B-2234-12 |
| Products: 10x10x18 Ilium Tricortical Block.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0004
NLGIN10-0038
|
Tissue ID #:
AI1000045005, AI1000045008, AI1000045011, AI1000385007
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
4 Tissues |
B-2235-12 |
| Products: 11-13x10x18 Ilium Tricortical Block
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0004
NLGIN10-0038
|
Tissue ID #:
AI1000045006, AI1000045009, AI1000385009, AI1000385012, AI1000385015, AI1000385017, AI1000385018
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
7 Tissues |
B-2236-12 |
| Products: 14-17x11x25 Ilium Tricortical Block.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0004
NLGIN10-0038
|
Tissue ID #:
AI1000045007, AI1000045010, AI1000385005, AI1000385006, AI1000385008, AI1000385010, AI1000385011, AI1000385013, AI1000385014
AI1000385016
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
10 Tissues |
B-2237-12 |
| Products: 150mm x 20mm Cortical Plate.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0047
|
Tissue ID #:
AI1000470205, AI1000470206, AI1000470207
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
3 Tissues |
B-2238-12 |
| Products: 200mm Tibia Shaft
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0033
|
Tissue ID #:
AI10110400105
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
1 Tissue |
B-2239-12 |
| Products: 5mm 30cc Cancellous Cubes.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0025
|
Tissue ID #:
AI1000252019, AI1000252020, AI1000252021
AI1000252023, AI1000252024, AI1000252025
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
6 Tissues |
B-2240-12 |
| Products: 8mm Cancellous Block.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0004
|
Tissue ID #:
AI1000040753, AI1000040754, AI1000040755, AI1000040756, AI1000040757, AI1000040758, AI1000040759, AI1000040760, AI1000040761, AI1000040762, AI1000040763, AI1000040771 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
12 Tissues |
B-2241-12 |
| Products: 9mm Cancellous Block.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0004
|
Tissue ID #:
AI1000040776, AI1000040777, AI1000040778,
AI1000040779
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
4 Tissues |
B-2242-12 |
| Products: 5mm Lordotic Cervical Cancellous Spacer
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0016
|
Tissue ID #:
AI1000163005
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
1 Tissue |
B-2243-12 |
| Products: 6mm Lordotic Cervical Cancellous Spacer.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0001
NLGIN10-0007
NLGIN10-0013
NLGIN10-0016
|
Tissue ID #:
AI1000013007, AI1000073006, AI1000073007, AI1000073010, AI1000073011, AI1000073013, AI1000073014, AI1000073016, AI1000073018, AI1000133008, AI1000133009, AI1000133010, AI1000163006, AI1000163007 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
14 Tissues |
B-2244-12 |
| Products: 7mm Lordotic Cervical Cancellous Spacer.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0007
NLGIN10-0013
NLGIN10-0016
|
Tissue ID #:
AI1000073024, AI1000073026, AI1000073028, AI1000133011, AI1000163008, AI1000163009, AI1000163010, AI1000163011, AI1000163012 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
9 Tissues |
B-2245-12 |
| Products: 5mm Lordotic Cervical Spacer.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0024
|
Tissue ID #:
AI1000244006, AI1000244015, AI1000244016, AI1000244017, AI1000244018
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
5 Tissues |
B-2246-12 |
| Products: 6mm Lordotic Cervical Spacer.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0012
NLGIN10-0024
NLGIN10-0069
|
Tissue ID #:
AI1000124005, AI1000124006, AI1000124007, AI1000124008, AI1000244022, AI1000244023, AI1000244024, AI1000244025, AI1000244026, AI1000244027, AI10110034011, AI10110034012, AI10110034013, AI10110034014, AI10110034015, AI10110034016, AI10110034017, AI10110034018, AI10110034019, AI10110034020, AI10110034021, AI10110034022, AI10110034023, AI10110034024, AI10110034025, AI10110034026, AI10110034028 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
27 Tissues |
B-2247-12 |
| Products: 7mm Lordotic Cervical Spacer.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0012
NLGIN10-0069
|
Tissue ID #:
AI1000124009, AI1000124010, AI1000124011, AI1000124012, AI1000124013, AI1000124014, AI1000124015, AI10110034029, AI10110034030, AI10110034031, AI10110034032 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
11 Tissues |
B-2248-12 |
| Products: Achilles with Bone Block.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0021
|
Tissue ID #:
AI1000210005, AI1000210006
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
2 Tissues |
B-2249-12 |
| Products: Achilles with Bone Block Pre-sized.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0004
NLGIN10-0009
NLGIN10-0012
NLGIN10-0016
NLGIN10-0033
NLGIN10-0038
NLGIN10-0047
NLGIN10-0069
|
Tissue ID #:
AI1000040006, AI1000090005, AI1000090006, AI1000120005, AI1000160005, AI1000160006, AI1000380015, AI1000380016, AI10110030006, AI10110400005, AI10110400006 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
11 Tissues |
B-2250-12 |
| Products: Achilles without Bone Block..
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0005
|
Tissue ID #:
AI1000050005, AI1000050006
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
2 Tissues |
B-2251-12 |
| Products: Medial Femur Hemi-Condyle.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0038
|
Tissue ID #:
AI1000380030
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
1 Tissue |
B-2252-12 |
| Products: Patella Tendon - Hemi Presized.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0016
NLGIN10-0016
NLGIN10-0016
NLGIN10-0016
NLGIN10-0021
NLGIN10-0021
NLGIN10-0021
NLGIN10-0024
NLGIN10-0024
NLGIN10-0025
NLGIN10-0025
NLGIN10-0033
NLGIN10-0038
NLGIN10-0038
NLGIN10-0066
NLGIN10-0066
NLGIN10-0069
NLGIN10-0069
NLGIN10-0069
|
Tissue ID #:
AI1000160007, AI1000160008, AI1000160009, AI1000160010, AI1000210007, AI1000210008, AI1000210009, AI1000240007, AI1000240008, AI1000250007, AI1000250008, AI1000380017, AI1000380018, AI1000660002, AI1000660003, AI10110030007, AI10110030008, AI10110030009, AI10110400007 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
19 Tissues |
B-2253-12 |
| Products: Patella Whole.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0004
NLGIN10-0009
NLGIN10-0012
|
Tissue ID #:
AI1000040007, AI1000040008, AI1000090007,
AI1000090008
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
4 Tissues |
B-2254-12 |
| Products: Peroneus Longus Tendon.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0004
NLGIN10-0005
NLGIN10-0009
NLGIN10-0012
NLGIN10-0016
NLGIN10-0024
NLGIN10-0038
NLGIN10-0047
NLGIN10-0069
NLGIN11-0051
|
Tissue ID #:
AI1000040013, AI1000040014, AI1000050012, AI1000090013, AI1000090014, AI1000120013, AI1000120014, AI1000160015, AI1000160016, AI1000240012, AI1000380010, AI1000470013, AI10110030014, AI10110030015, AI11060010013 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
15 Tissues |
B-2255-12 |
| Products: Semitendinosus/Gracilis Tendon .
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0033
NLGIN10-0047
|
Tissue ID #:
AI10110400014, AI1000470014
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
2 Tissues |
B-2256-12 |
| Products: Semitendinosus Tendon .
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN09-0024C
NLGIN10-0033
NLGIN10-0047
NLGIN10-0066
|
Tissue ID #:
AI090024C0011, AI1000470015, AI1000660009, AI1000660010, AI10110400015
|
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
5 Tissues |
B-2257-12 |
| Products: Tibialis Tendon - Anterior.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN09-0024C
NLGIN10-0004
NLGIN10-0005
NLGIN10-0009
NLGIN10-0012
NLGIN10-0013
NLGIN10-0016
NLGIN10-0021
NLGIN10-0024
NLGIN10-0025
NLGIN10-0033
NLGIN10-0038
NLGIN10-0047
NLGIN10-0066
NLGIN10-0069
NLGIN11-0051
|
Tissue ID #:
AI090024C0007, AI090024C0008, AI1000040010, AI1000050007, AI1000050008, AI1000090009, AI1000090010, AI1000120009, AI1000120010, AI1000130008, AI1000130009, AI1000160011, AI1000160012, AI1000210010, AI1000210011, AI1000240009, AI1000240010, AI1000250009, AI1000250010, AI1000380005, AI1000380006, AI1000470008, AI1000660004, AI1000660005, AI10110030010, AI10110030011, AI10110400008, AI10110400009 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
28 Tissues |
B-2258-12 |
| Products: Tibialis Tendon - Posterior.
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN09-0024C
NLGIN10-0004
NLGIN10-0005
NLGIN10-0009
NLGIN10-0012
NLGIN10-0013
NLGIN10-0016
NLGIN10-0021
NLGIN10-0024
NLGIN10-0025
NLGIN10-0033
NLGIN10-0038
NLGIN10-0066
NLGIN10-0069
|
Tissue ID #:
AI090024C0009, AI090024C0010, AI1000040011, AI1000040012, AI1000050009, AI1000050010, AI1000090011, AI1000090012, AI1000120011, AI1000120012, AI1000130010, AI1000160013, AI1000160014, AI1000210012, AI1000210013, AI1000240011, AI1000250011, AI1000250012, AI1000380007, AI1000380008, AI1000660006, AI10110030012, AI10110030013, AI10110400010, AI10110400011 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
25 Tissues |
B-2259-12 |
| Products: 5mm Cancellous Block
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Block***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0004
NLGIN10-0021
NLGIN10-0024
|
Tissue ID #:
AI1000040705, AI1000040706, AI1000210705, AI1000210706, AI1000210707, AI1000210708, AI1000210709, AI1000210710, AI1000210711, AI1000210712, AI1000240705, AI1000240706, AI1000240707, AI1000240708, AI1000240709, AI1000240710 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
16 Tissues |
B-2260-12 |
| Products: 6mm Cancellous Block
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Block***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0004
|
Tissue ID #:
AI1000040707, AI1000040708, AI1000040709, AI1000040710, AI1000040711, AI1000040712, AI1000040713, AI1000040714, AI1000040715, AI1000040716, AI1000040717, AI1000040718, AI1000040719, AI1000040720, AI1000040721, AI1000040722, AI1000040723, AI1000040724, AI1000040725, AI1000040726, AI1000040727, AI1000040728, AI1000040729, AI1000040730, AI1000040731 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
25 Tissues |
B-2261-12 |
| Products: 7mm Cancellous Block
Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Block***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***"
Donor ID #:
NLGIN10-0004
|
Tissue ID #:
AI1000040732, AI1000040733, AI1000040734, AI1000040735, AI1000040736, AI1000040737, AI1000040738, AI1000040739, AI1000040740, AI1000040741, AI1000040742, AI1000040743, AI1000040744, AI1000040750, AI1000040751, AI1000040752 |
Class III |
Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. |
16 Tissues |
B-2262-12 |
