| Class 2 Device Recall Howmedica HIp Stem | |
Date Initiated by Firm | November 28, 2006 |
Date Posted | January 13, 2007 |
Recall Status1 |
Terminated 3 on May 08, 2007 |
Recall Number | Z-0476-2007 |
Recall Event ID |
36973 |
Product Classification |
Hip Stem - Product Code KWL
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Product | Howmedica Hip Fracture Stem System
No. 4 Femoral Component
Fenestrated
Sterile REF Catalogue #6942-0-040
Made in Ireland |
Code Information |
Hip Fracture Stem # 4; Catalog number 6942-0-040; Lot codes: 7567401, 7799201, 7868901, 7868902, 7868903, 7936001, 7936002, 8243001, 8243002, 9401001, 9948301, 9948302, 9948304, 14342101, 17596001, 17596002, 17810901, 17969201, 18062501, 18062502, 18062503, 8243003R, MPRTA. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
|
For Additional Information Contact | Larry 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 |
Action | Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt. |
Quantity in Commerce | 67 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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