Recall Z-1642-2009 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Stryker Howmedica Osteonics Corp.
Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog number 6276-1-021, Catalog number 6276-1-025, Catalog number 6276-1-219, and Catalog number 6276-1-325. Howmedica Osteonics Corp, Stryker Ireland, Carrighwohill Sterile. Intended Use: For primary or revision total hip arthroplasty and severe proximal bone loss. Stems are intended to be used with Howmedica Os
| Date | May 21, 2009 (initiated Apr 2, 2009) |
| Status | Terminated |
| Reason | Packaging burst test values for the Restoration Modular Cone Body family were found to be incorrectly transferred from the finalized validation to the work specification. Testing showed that burst test results for recalled products fell below the validated parameters. |
| Root cause | Process control |
| Action | Urgent Product Recall letters were sent via Federal Express on April 2, 2009 to Stryker branches, Chief of Orthopaedics, Hospital Rick Management and Surgeons. The letter stated the issue, the potential hazards, and the risk mitigation. Customers were asked to examine their inventory and hospital locations to identify the affected products; retrieve all effected products and return it to their branch or agency warehouse for reconciliation; reconcile all products on the attached Product Accountability Form and fax a copy to the number listed; return the affected product via the Inter-Org Tran |
| Quantity | 17 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |