Recall Z-1251-2009 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Stryker Howmedica Osteonics Corp.
Modular Replacement System (MRS) Cemented Stems, Sterile, Catalog Numbers: 6485-3-000, 6485-3-008, 6485-3-009, 6485-3-010, 6485-3-018, 6485-3-019, 6485-3-300, 6485-3-308, 6485-3-309, 6485-3-310, 6485-3-318, and 6485-3-319. The Modular Replacement System has been successfully used in clinical in clinical situations where there is extensive bone loss due to tumor resection, and/or failed previous p
| Date | Apr 17, 2009 (initiated Jan 30, 2009) |
| Status | Terminated |
| Reason | Instruction for use incorrect: There are no statements or warning on labels or Instructions for Use that 8, 9 and 10 mm diameter MRS Cemented Stems are indicated only for use in the GMRS Proximal Tibial and Distal Femoral Components. |
| Root cause | Labeling False and Misleading |
| Action | Urgent Product Recall letters, dated 1/30/2009, were sent to all Branches/agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeons on January 30, 2009 via Federal Express. The letter asked consignees to examine their inventory and determine if they had any affected products, remove and quarantine affected product from their inventory, and complete the attached Product Recall Acknowledgment Form. The letter also stated that a Stryker Orthopaedics Sales representative would contact the consignee to reconcile and return the product . Consignees should contact their Stryker sales |
| Quantity | 1161 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040749 | MODULAR REPLACEMENT SYSTEM CEMENTED STEMS Howmedica Osteonics Corp., Jun 17, 2004 |