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Recall Observatory FDA recall evidence

Device product

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

Z-1741-2015

May 01, 2015

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 71255
Status
Terminated
Classification
Class II
Quantity
19
Official record key
device-enforcement:Z-1741-2015

Official wording

Reason: 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.

Code information: Part 14-450510 Lots:268000, 466170, and 813950

Distribution pattern: US Nationwide Distribution in the states of CA, TX, FL, NC, MI, GA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.