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

Recall Z-1644-2018 — RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

U.S. FDA — Device Enforcement · United States · 2017-12-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1644-2018
Date of alert
2017-12-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Mako Surgical Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
26080317
Reported risk: Incorrect product and/or label. Sizing is labeled incorrectly.
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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