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

Recall Z-0151-2018 — Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.

U.S. FDA — Device Enforcement · United States · 2017-09-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0151-2018
Date of alert
2017-09-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Exactech, Inc.
Product category
device
Product type
Devices
Reported risk: There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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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