Howmedica Osteonics Corp. Recall 91913
Description: stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Howmedica Osteonics Corp. Recall 91913 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1386-2023 |
| Event ID | 91913 |
| Event Description | stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure |
| Product Type | Devices |
| Distribution | U.S., Netherlands, Japan, China, India, Korea, and Australia. |
| Quantity | 102 units |
| Recall Reason | Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking |
| Device Classification | 20230419 |
| Device Code Info | GTIN 00848486003753, Lot Number 26250421 |
| Center Classification Date | 20230412 |
| Recall Initiation Date | 20230310 |
| Recalling Firm | Howmedica Osteonics Corp. |
| Initial Notification | Letter |
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