Recall Z-1822-2009
Stryker Howmedica Osteonics Corp. · initiated June 18, 2009
Product
V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Howmedica Osteonics Corp., Stryker Ireland, Carrigtwohill County Cork, Ireland; Intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
Codes / lots: lot # 29213701;Exp. 1/28/2014 and lot # 29228301; Exp 1/28/2014
Reason for recall
Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.
FDA-determined cause: Process control
Action taken
Urgent Product Recall letters were sent via Federal Express on June 18, 2009 to all Stryker Branches/Agencies, hospital Risk Management, hospital Chief of Orthopaedics and surgeons who may have used the recalled products. The letters stated the issue, potential hazards, and the risk mitigation. Customers may contact Colleen O'Meara at 201-831-5970 with any questions.
Details
- Recall number
- Z-1822-2009
- Initiated
- June 18, 2009
- Posted by FDA
- August 18, 2009
- Terminated
- August 27, 2012
- Product code
- LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Quantity
- 13 total, both products.
- Distribution
- Nationwide Distribution
- Recalling firm
- Stryker Howmedica Osteonics Corp., Mahwah, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1821-2009 | Dall Miles Cable Grip System; Catalog number 6704-0-210; Stryker Ireland. The Dall-Miles…Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected… | 06/18/2009Terminated |