CLASS II Device recall · Reported 17 Jun 2015 · FDA Enforcement Report

Unilateral external fixation ankle clamp recalled by Biomet

Biomet is recalling Unilateral external fixation ankle clamp, distributed nationwide in the US. The recall was initiated on 1 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart 14-450510 Lots:268000, 466170, and 813950

Quantity recalled19

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1741-2015
FDA event ID: 71255
Recalling firm: Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 1 May 2015
FDA classified: 9 Jun 2015
Reported: 17 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

1 May 2015	Recall initiated by company
9 Jun 2015	Classified by FDA	+39 days
17 Jun 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide California Florida Georgia Michigan North Carolina Texas

Stores named: Walmart

Questions about this recall

Is Unilateral external fixation ankle clamp recalled?

Yes. Biomet recalled Unilateral external fixation ankle clamp on 1 May 2015. The recall is Class II and its status is Terminated. Recall number Z-1741-2015.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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