FDA-Device2015-06-17Class II
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
Biomet, Inc.
Hazard
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.
Sold states
US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.
Affected count
19
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1741-2015Don't want to check this manually?
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