Recall Z-0931-2012 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Stryker Howmedica Osteonics Corp.
Duration packaging distributed by Stryker Orthopaedics, Limerick, Ireland Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Product Usage: Orthopaedic implants utilized for primary and revision hip and knee (total and unilateral); total shoulder and elbow replacement; replacement; and oncological surgical procedures related to tumor resection. All devices are manu
| Date | Jan 30, 2012 (initiated Sep 6, 2011) |
| Status | Terminated |
| Reason | As part of Stryker's quality process, a packaging discrepancy was identified in specific lots of Stryker's Duration packaging. |
| Root cause | Packaging |
| Action | Stryker sent an Urgent Product Recall notification letter and Product Recall Acknowledgment Form dated September 6, 2011 to all affected consignees via FedEx with return receipt. The letter identifed the product, problems, potential hazard, and instructions on how to handled the affected product. Consignees are instructed to Return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics. Consignees are advised to completed and fax back the attached Product Recall Acknowledgment Form within 5 days to (201) 831-6069. For questions call (201) 972-2100. |
| Quantity | 39,483 units |
| Distribution | Nationwide Distribution (USA) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112556 | ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS Howmedica Osteonics Corp., Sep 28, 2011 |