stryker MAKO RESTORIS MCK BASEPLATE TRIAL — Class II medical device recall Z-1386-2023
Ongoing recall by Howmedica Osteonics Corp., reported 2023-04-19. Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorr
| Recall number | Z-1386-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2023-03-10 |
| Classified | 2023-04-12 |
| Reported by FDA | 2023-04-19 |
| Countries outside the US | AU, CN, IN, JP, KR, NL |
| Quantity | 102 units |
| UPC / GTIN / UDI-DI | 00848486003753 |
| Lot numbers | 26250421 |
| Model numbers | 170616 |
Product
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Reason for recall
Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1386-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.