Recall Z-0884-2009 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Stryker Howmedica Osteonics Corp.
Restoration Modular Conical Distal Stem; Sterile, Titanium Alloy. One unit per package. Stryker Ireland Carrigtwohill County Cork, Ireland. Authorized Representative in Europe: Stryker France, Cedex France. This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of servere proximal bone loss.
| Date | Jan 26, 2009 (initiated Nov 21, 2008) |
| Status | Terminated |
| Reason | Stryker became aware of a lot for lot mix up. |
| Root cause | Labeling mix-ups |
| Action | Recall notification letters sent via Federal Express on Nov. 21, 2008 to Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeons. Letters explain the labeling mix up and the potential risks to patients if the wrong size stem is used. Stryker branches are asked to examine inventory and that of hospital locations to identify affected product. All affected product is to be reconciled on the Product Accountability form and the form faxed back to Stryker. Contact Stryker Howmedical Osteonics Corporation for additional information at 1-201-831-5718. |
| Quantity | 4 |
| Distribution | Class II Recall - Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022549 | RESTORATION MODULAR SYSTEM Howmedica Osteonics Corp., Sep 23, 2002 |