Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1386-2023 — stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure

U.S. FDA — Device Enforcement · United States · 2023-03-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1386-2023
Date of alert
2023-03-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Howmedica Osteonics Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00848486003753
Reported risk: Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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