Recall Z-2732-2024 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Howmedica Osteonics Corp.
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
| Date | Aug 26, 2024 (initiated Aug 5, 2024) |
| Status | Open, Classified |
| Reason | A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal. |
| Root cause | Process control |
| Action | On August 5, 2024 an URGENT MEDICAL DEVICE RECALL letter was sent to their consignee. Actions Needed: Our records indicate that you have received the affected product, and that product has already been returned to Stryker. We therefore request that you read this notice carefully and complete the following actions. 1. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form. Please assist us in meeting our regulatory obligation by emailing back the attached Urgent Medical Device Recall Business Reply Form within 5 days. We regret any inconvenience this action may cause. F |
| Quantity | 1 unit (OUS only) |
| Distribution | International distribution to the country of Australia. |
| FDA record | Open on fda.gov |