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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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 Class 2 Recall
Stryker
see related information
Date Posted January 30, 2012
Recall Status1 Open
Recall Number Z-0931-2012
Recall Event ID 60850
Premarket Notification
510(K) Number
K112556 
Product Classification Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate - Product Code MEH
Product Duration® packaging distributed by Stryker® Orthopaedics, Limerick, Ireland Stryker® Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Product Usage: Orthopaedic implants utilized for primary and revision hip and knee (total and unilateral); total shoulder and elbow replacement; replacement; and oncological surgical procedures related to tumor resection. All devices are manufactured from UHMWPE and are processed through post-sterilization (gamma irradiation) heat treatment for stabilization (i.e. Duration®® process). Launched in 1996, Duration®® Stabilized Polyethylene is produced by a patented process utilizing a combination of nitrogen packaging to reduce shelf oxidation, gamma irradiation (3Mrads) to sterilize and crosslink the polyethylene, and a post-irradiation stabilization step during which the components undergo a heat treatment process to promote further crosslin king and to enhance product wear resistance. In order to maintain the nitrogen environment over the shelf-life of the product, the packaging consists of double, nested PET blisters sealed with foil (non-gas permeable) Iidstock.
Code Information C-KM45-1-200 JADE #5 STAB INS 14MM -DUR C-KM45-1-201 JADE #5 STAB INS 16M1M -DUR C-KM45-1-202 JADE #5 STAB INS 12MM -DUR 62971044 BRUNSWIK CUP 1D 32MM 44MMO.D. 62971046 BRUNSWICK CUP 1D 32MM 46MMO.D. 62971048 BRUNSWICK CUP 1D 32MM 48MMO.D. 62971050 BRUNSWIK CUP 10 32MM 50MMO.D. 62971052 B~UNSWIK CUP 1D 32MM 52MMO.D. -- 62971054 BRUNSWIK CUP 1D 32MM 54MMO.D. 62971056 BRUNSWIK CUP 1D 32MM 56MMO.D. 62971058 BRUNSWIK CUP 10 32MM 58MMO.D. 62972048 BRUNSWICK ACE CUP 35MMX48MM 62972050 BRUNSWICK ACE CUP 35MMX50MM 62972052 I BRUNSWICK ACE CUlp 35MMX52MM 62972054 BRUNSWICK ACE CUP 35MMX54MM I 62972058 BRUNSWICK ACE CUP 35MMX58MM 64300020 . AVON PATELLA SMALL 64300030 AVON PATELLA MEDIUM 64300040 AVON PATELLA LARGE 64603004 HMRS MOD HUM H'UM BEARING 64603005 HMRS HUMERUS WEDGE 64603007 HMRS-HUMERUS, M4 ELBOW AXLE... 64656007 HMRS WEDGE -7 X 18 64656018 HMRS BEARING -18 X 24 64664308 HMRS-M8 FEMORAL JOINT PLUG SCR 64669100 FEMORAL FIXATION PLATE 64669200 TIBIAL FIXATION PLATE 64669240 M8 THREADED BUSH,(KIEL). 64669245 KMFTR REVISION BUSH 64669306 HMRS-M6 KNEE AXLE PLUG SCREW 64710808 8MM EX SML KIN 2 MOD TIB INSRT 64710811 11MM EX SML KIN2 MOD TIB INSRT 64710813 13MM EX SML KIN2 MOD TIB INSRT 64710816 16MM EX SML KIN2 MOD TIB INSRT 64711808 8MM SML KIN2 MOD TIBIAL INSERT 64711811 11MM SML KIN2 MOD TIB INSERT 64711813 13MM SML KIN2 MOD TIB INSERT 64711816 16MM SML KIN2 MOD TIB INSERT 64711900 -KIN COND KN SMALL PATELLA DOME 64713808 8MM MED KIN2 MOD TIBIAL INSERT 64713811 11MM MED KIN2 MOD TIB INSERT 64713813 13MM MED KIN2 MOD TIB INSERT 64713816 16MM MED KIN2 MOD TIB INSERT 64713900 KINEMATIC KN MED PATELLA DOME 64715808 8MM LRG KIN2 MOD TIBIAL INSERT 64715811 11MM LRG KIN2 MOD TIB INSERT 64715813 13MM LRG KIN2 MOD TIB INSERT 64715816 16MM LRG KIN2 MOD TIB INSERT 64715900 KINEMATIC KNEE PAT/DOME LRG 64716808 8MM EX LRG KIN2 MOD TIB INSERT 64716811 11MM EX LRG KIN2 MOD TIB INS 64716813 13MM EX LRG KIN2 MOD TIBINS 64716816 16MM EX LRG KIN2 MOD TIBINS 64720808 KMS X-SMALL HDP TIBIAL STABLZR 64720811 KMS X-SMALL HDP TIBIAL STABLZR 64720813 KMS X-SMALL HDP TIBIAL STABLZR 64720816 KMS X-SMALL HDP TIBIAL STABLZR 64721808 KMS 8MM SML HDP TIBIAL STABLZR 64721811 KMS 11MM SML HDP TIBL STABLZR 64721813 KMS 13MM SML HDP TIBL STABLZR 64721816 KMS 16MM SML HDP TIBL STABLZR 64723808 KMS 8MM MED HDP TIBIAL STABLZR 64723811 KMS 11MM MED HDP TIBL STABLZR 64723813 KMS 13MM MED HDP TIBL STABLZR 64723816 KMS16MM MED HDP TIBL STABLZR 64725808 KMS 8MM LRG HDP TIBIAL STABLZR 64725811 KMS 11MM LRG HDP TIBL STABLZR 64725813 KMS 13MM LRG HDP TIBt STABLZR 64725816 KMS 16MM LRG HDP TIBt STABLZR 64726808 KMS X-LARGE HDP TIBIAL STABLZR 64726811 KMS X-LARGE HDP TIBIAL STABLZR 64726813 KMS X-LARGE HDP TIBIAL STABLZR 64726816 KMS X-LARGE HDP TIBIAL STABLZR 64780410 KMX+ REV TSINSERT -XS 10MM 64780412 KMX+ REV TSINSERT XS 12MM 64780415 KMX+ REV TS INSERTXS15MM 64780418 KMX+ REV TS INSERT XS 18MM 64780421 KMX+ REV TS INSERT XS 21MM 64780425 KMX+ REV TS INSERT XS 25MM 64781410 I KMX + 'REV TS INSERT SML 10MM 64781412 I KMX+ REV TS INSERT SML 12MM 64781415 KMX+ REV TS INSERT SML 15MM 64781418 KMX+ REV TS INSERT SML 18MM 64781421 KMX+ REV TS INSERT SML 21MM 64781425 KMX+ REV TS INSERT SML 25MM 64783410 KMX+ REV TS INSERT MED 10MM 64783412 KMX+ REV TS INSERT MED 12MM 64783415 KMX + REV TS INSERT MED 15MM 64783418 KMX + REV TS INSERT MED 18MM 64783421 KMX + REV TS INSERT MED 21MM 64783425 KMX + REV TS INSERT MED 25MM 64785410 KMX + REV TS INSERT LRG 10MM 64785412 KMX + REV TS INSERT LRG 12MM 64785415 KMX + REV TS INSERT LRG 15MM 64785418 KMX + REV TS INSERT tRG 18MM 64785421 KMX + REV TS INSERT LRG 21MM 64785425 KMX + REV TS INSERT LRG 25MM 64787410 KMX + REV TS INSET XLRG 10MM 64787412 KMX + REV TS INSERT XLRG 12MM 64787415 KMX + REV TS INSERT XLRG 15MM 64787418 KMX + REV TS INSERT XLRG 18MM 64787421 KMX + REV TS INSERT XLRG 21MM 64787425 KMX + REV TS INSERT XLRG 25MM 64791108 KX MOB INSRT SM 8MM L 64791310 KX MOB INSRT MED 10MM L 64791510 KX MOB INSRT LGE 10MM L 64791515 KX MOB INSRT LGE 15MM L 64793108 II KX MOB INSRT SM 8MM R 64793308 I KX MOB INSRT MED 8MM R 64793508 KX MOB INSRT LGE 8MM R 64793510 KX MOB INSRT LGE 10MM R 64794900 KX+ DURATION PATELLA SM 64794911 KX+ DURATION PATELLA MED 64794920 KX+ DURATION PATELLA LRG 64795008 KX+ DURAT LS INSERT XS 8MM 64795010 KX+ DURAT LS INSERT XS 10MM 64795012 KX+ DURAT LS INSERT XS 12MM 64795015 KX+ DURAT LS INSERT XS 15MM 64795018 KX+ DURAT LA INSERT XS 18MM 64795021 KS+ DURAT LS INSERT XS 21MM 64795025 KX+ DURAT LS INSERT XS 25MM 64795108 KX+ DURAT LS INSERT SM 8MM 64795110 KX+ DURAT LS INSERT SM 10MM 64795112 KX+ DURAT LS INSERT SM 12MM 64795115 KX+ DURAT LS INSERT SM 15MM 64795118 KX+ DURAT LS INSERT SM 18MM 64795121 KX+ DURAT LS INSERT SM 21MM 64795125 KX+ DURAT LS INSERT SM 25MM 64795208 KX+ DURAT LS INSERT MED 8MM 64795210 KX+ DURAT LS INSERT MED 10MM 64795212 KX+ DURAT INSERT MED 12MM 64795215 KX+ DURAT LS INSERT MED 15 64795218 KX+ DURAT LS INSERT MED 18MM 64795221 KX+ DURAT LS INSERT MED 21MM 64795225 KX+ DURAT LS INSERT MED 25MM 64795308 KX+ DURAT LS INSERT LRG 8MM 64795310 KX+ DURAT LS INSERT LRG 10MM 64795312 KX+ DURAT LS INSERT LRG 12MM 64795315 KX+ DURAT LS INSERT LRG 15MM 64795318 KX+ DURAT LS INSERT LRG 18MM 64795321 KX+ DURAT LS INSERT LRG 21MM 64795325 KX+ DURAT LS INSERT LRG 25MM 64795408 KX+ DURAT INSERT XL 8MM 64795410 KX+ DURAT LS INSERT XL 10MM 64795412 KX+ DURAT LS INSERT XL 12MM 64795415 KX+ DURAl LS INSERT XL 15MM 64795418 KX+ DURAT LS INSERT XL 18MM 64795421 KX+ DURAT LS INSERT XL 21MM 64795425 KX+ DURAT LS INSERT XL 25MM 64795508 KX+ DURAT STAB INSERT XS 8MM 64795510 KX+ DURAT STAB INSERT XS 10MM 64795512 KX+ DURAT STAB INSERT XS 12MM 64795515 KX+ DURAT STAB INSERT XS 15MM 64795518 KX+ DURAT STAB INSERT XS 18MM 64795521 KX+ DURAT STAB INSERT XS 21MM 64795525 KX+ DURAT STAB INSERT XS 25MM 64795608 KX+ DURAT STAB INSERT SM 8MM 64795610 KX+ DURAT STAB INSERT SM 10MM 64795612 KX+ DURAT STAB INSERT 12MM 64795615 KX+ DURAT STAB INSERT SM 15MM 64795618 KX+ DURAT STAB INSERT SM 18MM 64795621 KX+ DURAT STAB INSERT SM 21MM 64795625 KX+ DURAT STAB INSERT SM 25MM 64795708 KX+ DURAT DTAB 'INSERT MED 8MM 64795710 KX+ DURAT STAB INSERT MED 10MM 64795712 KX+ DURAT STAB INSERT MED 12MM 64795715 KX+ DURAT STAB INSERT MED 15MM 64795718 KX+ DURAT STAB INSERT MED 18MM 64795721 I[ KX+ DURAT STAB INSERT MED 21MM 64795725 I KX+ DURAT STAB INSERT M ED 25MM 64795808 I KX+ DURAT STAB INSERT LRG 8MM 64795810 KX+ DURATSTAB INSERT LRG 10MM 64795812 KX+ DURAT STAB INSERT LRG 12MM 64795815 KX+ DURAT STAB INSERT LRG 15MM 64795818 KX+ DURAT STAB INSERT LRG 18MM 64795821 KX+ DURAT STAB INSERT LRG 21MM 64795825 KX+ DURAT STAB INSERT LRG 25MM 64795908 KX+ DURAT STAB INSERT XL 8MM 64795910 KX+ DURAT STAB INSERT XL 10MM 64795912 KX+ DURAT STAB INSERT XL 12MM 64795915 KX+ DURAT STAB INSERT XL 15MM 64795918 KX+ DURAT STAB INSERT XL 18MM 64795921 KX+ DORAT STAB INSERT XL 21MM 64795925 KX+ DURAT STAB INSERT XL 25MM 64812110 MRHK FEMORAL BUSHING 64812130 MRHK BUMPER INSERT -NEUTRAL 64812133 MRHK BUMPER INSERT 3 DEGREES 64812140 64812150 MRHK TIBIAL SLEEVE MRH HDP ASSEMBLY PACK . I 64813210 MRHK HB INS 10MM XS/S S1/S2 64813213 MRHK TIB INS 13MM XS/S S1/S2 64813216 MRHK TIB INS 16MM XS/S S1/S2 64813220 MRHK TIB INS 20MM XS/S S1/S2 64813224 MRHK TIB INS 24MM XS/S S1/S2 64813310 MRHK TIB INS 10MM M/L M2/L2 64813313 MRHK TIB INS 13MM M/L M2/L2 I 64813316 MRHK TIB INS 16MM MD/LG M2/L2 64813320 MRHK TIB INS 20MM MD/LG M2/L2 64813324 ! MRHK TIB INS 24MM M/L M2/L2 64821250 KMAX+ ROT KN MED FEM BUSH 64822150 KMAX+ ROT KN MED BUMPER INSERT 64823153 KMAX+ ROT KN MEDTIB INS 6MM Page.5 of 16 64823155 KMAX+ ROT KN MED TIB INS 10MM 64823157 KMAX+ ROT KN MED TIB INS 14MM 64823350 KMAX+ ROT KN MED TIB SLEEVE 64831250 HMRS ROT HINGE FEM BUSHING 64832150 HMRS ROT HINGE BUMPER 0 DEG 64832153 HMRS ROT HINGE BUMPER 3 DEG 64832155 HMRS ROT HINGE BUMPER 5 DEG 64833106 HMRS ROT HINGE TIB INSERT 6MM 64833110 HMRS ROT HINGE TIB INSERT 10MM 64833114 HMRS ROT HINGE TIB INSERT 14MM 64851915 KINEMATIC PATELLA SML 64852008 XSML KRH ALL POLY TIBIA 8MM 64852011 XSMALL KRH ALL POLYTIBIA llMM 64852016 XSMALL KRH ALL POLY TIBIA 16MM 64852021 XSMALL KRH ALL POLY TIBIA 21MM 64852108 SMALL KRH ALL POLY TIBIA 8MM 64852111 SMALL KRH ALL POLY TIBIA 11MM 64852116 SMALL KRH ALL POLY TIBIA 16MM 64852121 SMALL KRH ALL POLY TIBIA 21MM 64852208 MEDIUM KRH ALL POLY TIBIA 8MM 64852211 MEDIUM KRH ALL POLY TIBIA 11MM 64852216 MEDIUM KRH ALL POLY TIBIA 16MM 64852221 MEDIUM KRH ALL POLY TIBIA 21MM 64852308 LARGE KRH ALL POLY TIBIA 8MM 64852311 LARGE KRH ALLPOLYTIBIA 11MM 64852316 LARGE l
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
For Additional Information Contact Ms. Colleen O'Meara
201-972-2100
Manufacturer Reason
for Recall
As part of Stryker¿'s quality process, a packaging discrepancy was identified in specific lots of Stryker¿'s Duration¿ packaging.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action Stryker sent an Urgent Product Recall notification letter and Product Recall Acknowledgment Form dated September 6, 2011 to all affected consignees via FedEx with return receipt. The letter identifed the product, problems, potential hazard, and instructions on how to handled the affected product. Consignees are instructed to Return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics. Consignees are advised to completed and fax back the attached Product Recall Acknowledgment Form within 5 days to (201) 831-6069. For questions call (201) 972-2100.
Quantity in Commerce 39,483 units
Distribution Nationwide Distribution (USA)
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MEH and Original Applicant = HOWMEDICA OSTEONICS CORP
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