Recall Z-0925-2008 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Stryker Howmedica Osteonics Corp.
Stryker Modular Replacement System Curved Cemented Stem; MRS 13x127 Curved Femoral Stem. Catalog Number: 6485-3-713; Stryker Orthopaedics Mahwah, NJ 07430
| Date | Feb 26, 2008 (initiated Nov 15, 2007) |
| Status | Terminated |
| Reason | Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants. |
| Root cause | Process design |
| Action | On November 26, 2007, Stryker Sent Urgent Product Recall notification letters to Stryker Agencies/Branches and hospitals (OR Supervisor) by Federal Express. The notification requested that all inventory be examined and returned. Returning instructions were provided in the letter. Questions concerning this recall are being addressed by contacting the Regulatory Compliance Hotline at (201) 831-6633. |
| Quantity | 803 total, all sizes |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952970 | HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM Howmedica Corp., Jan 17, 1996 |