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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-0476-2007 |
| Recall Event ID |
36973 |
| Product Classification |
Hip Stem - Product Code KWL
|
| 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
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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.
|
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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