Recall Z-1386-2023 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Howmedica Osteonics Corp.
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
| Date | Apr 12, 2023 (initiated Mar 10, 2023) |
| Status | Open, Classified |
| Reason | Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking |
| Root cause | Process change control |
| Action | Stryker issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 03/10/2023 by letter. The notice explained the issue and the hazard and requested the following actions be taken: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the affected products in Table 1. 4. Complete and sign the enclosed Urgent Medical Device R |
| Quantity | 102 units |
| Distribution | U.S., Netherlands, Japan, China, India, Korea, and Australia. |
| FDA record | Open on fda.gov |