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

Recall Z-1741-2015 — Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality

U.S. FDA — Device Enforcement · United States · 2015-05-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1741-2015
Date of alert
2015-05-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Biomet, Inc.
Product category
device
Product type
Devices
Reported risk: Ankle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents complete range of motion and if pushed too far may loosen the pin from the bone. A revision surgery may be necessary to adequately reconnect the fixator to the bone.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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