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Terminated

Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint

FDA Recall Z-0521-2015 · Posted 2014-12-16

Recalling FirmBiomet Microfixation, LLC
Recall StatusTerminated
Product CodeLZD
Date Initiated2014-10-17
Date Terminated2017-01-04
Product Quantity42

Reason for Recall

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

Firm Action

BIOMET sent an Urgent Medical Device Recall letter dated October 17, 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following steps: 1) Immediately locate and remove from circulation the items invoiced/consigned/loaned to your account. 2) Carefully follow the instructions on the enclosed "Response Form." and 3)If you have further distributed these items to medical facilities, you must notify them of this action. For questions customers were instructed to call 1-800-874-7711 or 904-741-4400, extension 9448, Monday through Friday, 8 a.m. to 4 p.m. EST. For questions regarding this recall call 904-741-9448.

Root Cause

Software Design Change

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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