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Class 2 Device Recall Howmedica HIp Stem |
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Date Initiated by Firm |
November 28, 2006 |
Date Posted |
January 13, 2007 |
Recall Status1 |
Terminated 3 on May 08, 2007 |
Recall Number |
Z-0472-2007 |
Recall Event ID |
36973 |
Product Classification |
Hip Stem - Product Code KWL
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Product |
Howmedica Hip Fracture Stem System, Product Number: 6942-0-10, No. 1 Femoral Component, Fenestrated Sterile
Made in Ireland |
Code Information |
Hip Fracture Stem # 1; Catalog Number 6942-0-010; Lot codes: 6499601, 6660201, 6660202, 6660203, 6660204, 6660205, 7237401, 7237402, 7237403, 7237404, 7237405, 7934101, 7934102, 7934103, 7934104, 7934105, 8345801, 8345802, 8345803, 8345804, 9714001, 9911901, 9911902, 10420701, 10420702, 10756001, 11319201, 11369101, 11369102, 11369103, 11605201, 11605202, 13093201, 13093301, 13093302,13093401, 13093501, 13562501, 13562502, 13782001, 15550502, 16060001, 16060002, 16840301, 17289301, 17289302, 18448101, 18448102, 18448103, 18593901, 14413201R, P4FEA. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
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For Additional Information Contact |
Larry Ross 201-831-5972
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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.
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FDA Determined Cause 2 |
Other |
Action |
Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt. |
Quantity in Commerce |
193 units |
Distribution |
Nationwide |
Total Product Life Cycle |
TPLC Device Report
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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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