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

Recall Z-0438-2013 — IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.

U.S. FDA — Device Enforcement · United States · 2011-04-25 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0438-2013
Date of alert
2011-04-25
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Extremity Medical LLC
Product category
device
Product type
Devices
Reported risk: Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.
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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