Device product

Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint

Z-0518-2015

October 17, 2014

Class II

Product summary

Firm: Biomet Microfixation, LLC
Event: Event 69644
Status: Terminated
Classification: Class II
Quantity: 42
Official record key: device-enforcement:Z-0518-2015

Official wording

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

Code information: Model 24-6551TI, Lot #s: 544160A, 525190A, 525190B, 525180B, 544170A, 544180B, 544160B, 525180A, 544180A.

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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