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U.S. Department of Health and Human Services

Class 2 Device Recall Howmedica HIp Stem

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 Class 2 Device Recall Howmedica HIp Stemsee related information
Date Initiated by FirmNovember 28, 2006
Date PostedJanuary 13, 2007
Recall Status1 Terminated 3 on May 08, 2007
Recall NumberZ-0474-2007
Recall Event ID 36973
Product Classification Hip Stem - Product Code KWL
ProductHowmedica Hip Fracture Stem System No. 3 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-030 Made in Ireland
Code Information Hip Fracture Stem # 3; Catalog number 6942-0-030, Lot codes: 7238602, 7238603, 7238604, 7353002, 7353003, 7600501, 7600502, 7692501, 7692503, 7692504, 7692505, 7292506, 7935101, 7935102, 7935103, 7999701, 7999702, 7999703, 7999801, 7999803, 8152201, 8152203, 8152204, 8152205, 8152206, 8152207, 8152208, 8241801, 8241802, 8242101, 8252102, 8242103, 8345503, 8345504, 8531601, 8531901, 8532001, 8532301, 8532401, 8532501, 8532601, 8643301, 8643302, 8643303, 8643304, 8643305, 8850801, 8850802, 8850901, 8850902, 8850903, 9011101, 9044301, 9044302, 9044303, 9044304, 9090101, 9124401, 9400801, 9400802, 9400803, 9503202, 9574801, 9911802, 9911803, 9948101, 9948102, 10164601, 10164602, 10212501, 10317501, 10353702, 10353703, 10917801, 10917802, 10917803, 10917804, 10917806, 11064501, 11064503, 11092701, 11092702, 11092703, 11092704, 11092705, 11369401, 11369402, 11605501, 11607801, 12407001, 12407003, 12407005, 12407006, 12870602, 12870603, 12870604, 12947201, 12947202, 12947203, 13294601, 13294602, 13294603, 13294604, 13294605, 13294606, 13412101, 13412102, 13412103, 13412104, 13782202, 13782203, 13782204, 13782205, 14377903, 14412801, 14412804, 14412805, 14682701, 14682702, 14738901, 15236201, 15550301, 15550302, 15550303, 16059701, 16059703, 16059704, 16059705, 16059706, 16165503, 16499502, 16750801, 16937801, 16937802, 16937803, 16937804, 16937805, 16937806, 17540401

17540402, 17657902, 17657903, 17745101, 17842801, 17842802, 17842803, 18062101, 18062202, 18131401, 18131402, 18131403, 18448701, 18448702, 18594201, 18594202, 18594203, 18946901, 18946902, 19428801, 19673002, 19673003, 19673004, 19726201, 20304601, 20304602, 20304604, 20304607, 7023401R.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information ContactLarry Ross
201-831-5972
Manufacturer Reason
for Recall		Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.
FDA Determined
Cause 2		Other
ActionRecall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.
Quantity in Commerce540 units
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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