CLASS II Device recall · Reported 17 Dec 2014 · FDA Enforcement Report

Total Temporomandibular Joint Replacement System- Rt recalled

Biomet Microfixation is recalling Total Temporomandibular Joint Replacement System- Rt Standard Ti Mand Reconstruction of, distributed nationwide in the US. The recall was initiated on 17 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 24-6650TI, Lot #s: 518480B, 518480A, 525970A, 525970B, 525980B, 518490A, 526070A, 525990A, 525990B, 526060A, 526060B, 526070B, 525980A, 550330A, 550330B, 550340A, 550340B, 550350A, 550360A, 550360B, 518490B, 525960A, 525960B,

Quantity recalled42

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-0517-2015
FDA event ID: 69644
Recalling firm: Biomet Microfixation, Jacksonville, FL
Classification: Class II
Status: Terminated
Recall initiated: 17 Oct 2014
FDA classified: 8 Dec 2014
Reported: 17 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

17 Oct 2014	Recall initiated by company
8 Dec 2014	Classified by FDA	+52 days
17 Dec 2014	Published in enforcement report	+9 days

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

Reason for recall

Laser etching on the parts is wider and deeper than the conditions previously validated.

Product as listed by the FDA

Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint

Where it was distributed

Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.

Nationwide California Minnesota Pennsylvania

Questions about this recall

Is Total Temporomandibular Joint Replacement System- Rt Standard Ti Mand Reconstruction of recalled?

Yes. Biomet Microfixation recalled Total Temporomandibular Joint Replacement System- Rt Standard Ti Mand Reconstruction of on 17 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0517-2015.

Why was it recalled?

Laser etching on the parts is wider and deeper than the conditions previously validated.

Which lots are affected?

Model 24-6650TI, Lot #s: 518480B, 518480A, 525970A, 525970B, 525980B, 518490A, 526070A, 525990A, 525990B, 526060A, 526060B, 526070B, 525980A, 550330A, 550330B, 550340A, 550340B, 550350A, 550360A, 550360B, 518490B, 525960A, 525960B,

Where was it sold?

Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.

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.

More recalls from Biomet Microfixation

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