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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Sterile custom surgical procedure packs:
(1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hosp...
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2
|
06/07/2023
|
DeRoyal Industries Inc
|
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6
Tilastan, cement...
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2
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06/01/2023
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Linkbio Corp.
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Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers:
a) REF 1-...
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2
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05/31/2023
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Smith & Nephew, Inc.
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Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-1001...
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2
|
05/31/2023
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Smith & Nephew, Inc.
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Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-100...
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2
|
05/31/2023
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Smith & Nephew, Inc.
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Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers:
a) ...
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2
|
05/31/2023
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Smith & Nephew, Inc.
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TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement
Catalog Number: 5532-...
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2
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05/30/2023
|
Howmedica Osteonics Corp.
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TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement
Catalog Number: 5531-...
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2
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05/30/2023
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Howmedica Osteonics Corp.
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LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, SMALL
Item Number: 15-2020/40
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2
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05/04/2023
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Linkbio Corp.
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LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, MEDIUM SMALL
Item Number: 15-2020/46
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2
|
05/04/2023
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Linkbio Corp.
|
LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, MEDIUM
Item Number: 15-2020/52
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, Large
Item Number: 15-2020/60
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 45MM
Item Number: 15-2028/01
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2
|
05/04/2023
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Linkbio Corp.
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LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9MM X 45MM
Item Number: 15-2028/02
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2
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05/04/2023
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Linkbio Corp.
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LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11MM X 45MM
Item Number: 15-2028/03
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2
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05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13MM X 45MM
Item Number: 15-2028/04
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 50MM
Item Number: 15-2028/05
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2
|
05/04/2023
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Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9MM X 50MM
Item Number: 15-2028/06
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11MM X 50MM
Item Number: 15-2028/07
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2
|
05/04/2023
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Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13MM X 50MM
Item Number: 15-2028/08
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2
|
05/04/2023
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Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 55MM
Item Number: 15-2028/09
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2
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05/04/2023
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Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9MM X 55MM
Item Number: 15-2028/10
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2
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05/04/2023
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Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11MM X 55MM
Item Number: 15-2028/11
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13MM X 55MM
Item Number: 15-2028/12
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 58MM
Item Number: 15-2028/13
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9X58MM
Item Number: 15-2028/14
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11X58MM
Item Number: 15-2028/15
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13X58MM
Item Number: 15-2028/16
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM
Item Number: 15-2030/02
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System:
ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM
Item Number: 15-2030/03
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM
Item Number: 15-2030/04
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM
Item Number: 15-2030/06
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM
Item Number: 15-2030/07
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM
Item Number: 15-2030/08
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM
Item Number: 15-2030/10
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM
Item Number: 15-2030/11
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM
Item Number: 15-2030/12
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM
Item Number: 15-2030/13
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM
Item Number: 15-2030/14
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM
Item Number: 15-2030/15
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO SLED KNEE FEM COMP, SMALL
Item Number: 15-2220/40
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL
Item Number: 15-2220/46
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO SLED KNEE FEM COMP, MEDIUM
Item Number: 15-2220/52
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO SLED KNEE FEM COMP, LARGE
Item Number: 15-2220/60
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM
Item Number: 15-2230/02
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM
Item Number: 15-2230/03
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM
Item Number: 15-2230/04
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM
Item Number: 15-2230/06
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2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM
Item Number: 15-2230/07
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM
Item Number: 15-2230/08
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM
Item Number: 15-2230/10
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM
Item Number: 15-2230/11
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM
Item Number: 15-2230/12
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM
Item Number: 15-2230/13
|
2
|
05/04/2023
|
Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM
Item Number: 15-2230/14
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2
|
05/04/2023
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Linkbio Corp.
|
LINK SLED Knee System
POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM
Item Number: 15-2230/15
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2
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05/04/2023
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Linkbio Corp.
|
Sterile surgical convenience kits:
1. regard Item Number: 880473001, OR01105A - Total Shoulder/...
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2
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04/25/2023
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ROi CPS LLC
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EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
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2
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04/12/2023
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Encore Medical, LP
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stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial ...
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2
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04/12/2023
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Howmedica Osteonics Corp.
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stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial ...
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2
|
04/12/2023
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Howmedica Osteonics Corp.
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EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706;
EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7,...
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2
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02/27/2023
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Encore Medical, LP
|
Sterile Procedural Trays, labeled as the following:
a. UNIVERSAL PLASTIC
b. KNEE ARTHROSCOPY PA...
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2
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02/06/2023
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MEDLINE INDUSTRIES, LP - Northfield
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Sterile Procedural Trays, labeled as the following:
a. EP LAB PACEMAKER PACK
b. OPEN HEART CDS
c. O...
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2
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02/06/2023
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MEDLINE INDUSTRIES, LP - Northfield
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Sterile Procedural Trays, labeled as the following:
a. SPINAL
b. SPINE CDS
c. TOTAL ORTHO CDS
d. ...
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2
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02/06/2023
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MEDLINE INDUSTRIES, LP - Northfield
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Sterile Procedural Trays, labeled as the following:
a. KNEE ARTHROSCOPY CDS-LF
b. ARTHROSCOPY ...
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2
|
02/06/2023
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MEDLINE INDUSTRIES, LP - Northfield
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(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement pros...
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2
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01/30/2023
|
Biomet, Inc.
|
(1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement pro...
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2
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01/30/2023
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Biomet, Inc.
|
Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
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2
|
01/27/2023
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MEDLINE INDUSTRIES, LP - Northfield
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Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case
|
2
|
01/27/2023
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MEDLINE INDUSTRIES, LP - Northfield
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OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement...
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2
|
01/27/2023
|
Biomet, Inc.
|
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint...
|
2
|
01/26/2023
|
Biomet, Inc.
|
Various Custom Surgical Instrument Disposable Kits:
Part Numbers / Product Description
26000004M C...
|
2
|
01/04/2023
|
Windstone Medical Packaging, Inc.
|
DeRoyal TOTAL KNEE PACK, REF 89-9300.08
|
2
|
12/15/2022
|
DeRoyal Industries Inc
|
GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02
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2
|
12/15/2022
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DeRoyal Industries Inc
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GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09
|
2
|
12/15/2022
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DeRoyal Industries Inc
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GEO-MED TOTAL KNEE PACK A & B PGYK, REF 89-5796.13
|
2
|
12/15/2022
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DeRoyal Industries Inc
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GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07
|
2
|
12/15/2022
|
DeRoyal Industries Inc
|
DeRoyal TOTAL KNEE PACK A & B PACK, REF 89-6799.02
|
2
|
12/15/2022
|
DeRoyal Industries Inc
|
HENRY SCHEIN, Knee Pack, Item No.570-2908,
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2
|
12/14/2022
|
Stradis Medical, LLC dba Stradis Healthcare
|
EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
|
2
|
11/22/2022
|
MicroPort Orthopedics Inc.
|
EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
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2
|
11/22/2022
|
MicroPort Orthopedics Inc.
|
Unity Total Knee System.
Used for knee prosthesis in total knee replacement
|
2
|
11/21/2022
|
Corin Ltd
|
Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various ty...
|
2
|
11/08/2022
|
Beaver Visitec International, Inc.
|
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
|
2
|
10/21/2022
|
Encore Medical, LP
|
OSSUR Power Knee REF PKA10003
OSSUR Power Knee REF PKA10003
OSSUR Power Knee REF PKA01001L
...
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2
|
09/28/2022
|
Ossur Americas
|
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
|
2
|
09/23/2022
|
Howmedica Osteonics Corp.
|
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. in...
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2
|
07/15/2022
|
Aesculap Implant Systems LLC
|
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
|
2
|
06/09/2022
|
Encore Medical, LP
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1) ACS Arthroscopy Kit
2) ACS Knee Kit
3) ACS Hand Pack
|
2
|
05/06/2022
|
American Contract Systems, Inc.
|
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic ma...
|
2
|
04/29/2022
|
restor3d Inc.
|
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual ...
|
2
|
04/29/2022
|
restor3d Inc.
|
iTotal Identity Posterior Stabilised (PS) Knee Replacement System
Model Number: TPS-301-1113-020101
|
2
|
04/08/2022
|
Conformis, Inc.
|
Total Knee Pack - Surgical Kit
|
2
|
04/04/2022
|
Stradis Medical, LLC dba Stradis Healthcare
|
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
|
2
|
03/03/2022
|
Orthosoft, Inc. dba Zimmer CAS
|
ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty ...
|
2
|
02/09/2022
|
DePuy Orthopaedics, Inc.
|
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthropl...
|
2
|
02/09/2022
|
DePuy Orthopaedics, Inc.
|
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in prep...
|
2
|
01/06/2022
|
Howmedica Osteonics Corp.
|
United Orthopedics USTAR II Knee System
USTAR II Knee System Segment Part, RHS, 25 mm Length, Cat...
|
2
|
10/14/2021
|
Uoc Usa Inc
|
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement
Part Code:15230700...
|
2
|
10/07/2021
|
DePuy Orthopaedics, Inc.
|
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following:
a. TRULI...
|
2
|
10/04/2021
|
Exactech, Inc.
|