Recall Z-1822-2009 ยท LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Stryker Howmedica Osteonics Corp.
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.
| Date | Aug 18, 2009 (initiated Jun 18, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 13 total, both products. |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |