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

Recall Z-2668-2017 — EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46

U.S. FDA — Device Enforcement · United States · 2017-05-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2668-2017
Date of alert
2017-05-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Exactech, Inc.
Product category
device
Product type
Devices
Reported risk: Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
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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