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

Recall Z-0344-2013 — IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the sma

U.S. FDA — Device Enforcement · United States · 2011-04-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0344-2013
Date of alert: 2011-04-13
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 that lag screw passes through washer (e.g. X-Post) intra-operatively.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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