Recall Z-0193-2012 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Stryker Howmedica Osteonics Corp.
Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France The Restoration ADM System X# Acetabular Insert is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This de
| Date | Nov 16, 2011 (initiated Jun 3, 2011) |
| Status | Terminated |
| Reason | Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used. |
| Root cause | Labeling False and Misleading |
| Action | The firm, Stryker, sent an "URGENT PRODUCT CORRECTION" letter and Product Correction Bulletin dated June 3, 2011 via Fed Ex to its customers. The letter and bulletin describes the issue, potential hazards, risk mitigation and product correction instructions. The customers were instructed to complete and return the enclosed PRODUCT CORRECTION ACKNOWLEDGMENT FORM within 5 days via fax to: 201-831-6069. If you have any questions, feel free to call (201) 972-2100 or Hip Marketing Team at 201-831-5280. |
| Quantity | 1677 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093644 | RESTORATION ADM SYSTEM X3 ACETABULAR Howmedica Osteonics Corp., Dec 18, 2009 |