Recall Z-1201-2010 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Stryker Howmedica Osteonics Corp.
Howmedica Restoration ADM Trial Cup Holder; Non Sterile; Benoist Girard, Cedex, France; Distributed by Howmedica Osteonics Corp. Mahwah, NJ. The intended use: The Restoration ADM Window Trial is locked onto the Restoration ADM Trial Cup Holder and placed into the acetabulum to evaluate the size and congruity of the preparation for visualization and assessment of fit, contact and congruency of the
| Date | Apr 19, 2010 (initiated Jan 21, 2010) |
| Status | Terminated |
| Reason | The Restoration ADM Trial Cup Holder may not have been assembled correctly. |
| Root cause | Other |
| Action | An "URGENT PRODUCTION OPERATION" letter dated January 21, 2010, was sent to customers via FedEx. The letter described the product, problem and actions to be taken by customer. The customers should follow the instructions on the enclosed PRODUCT BULLETIN. The customer should check their internal inventory immediately and quarantine all affected devices, identify if the device is correctly assembled and complete the Product Correction Acknowledgement Form and fax it to (201) 831-6069. If you have any questions, feel free to contact Rich Wolyn, Manager, Divisional Regulatory Reporting at (20 |
| Quantity | 5 units |
| Distribution | Nationwide distribution: AZ, CA and OR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.