Biomet Microfixation, LLC: Medical Device Recall in 2014 - (Recall #: Z-0511-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint

Product Classification:

Class II

Date Initiated: October 17, 2014

Date Posted: December 17, 2014

Recall Number: Z-0511-2015

Event ID: 69644

Reason for Recall:

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

Status: Terminated

Product Quantity: 42

Code Information:

Model 01-6545TI, Lot #s: 535380D, 531850A, 531850B, 531860A, 531860B, 535380B, 535380C, 535380A.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated