Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joi

FDA device recall Z-0514-2015 · posted 2014-12-16 · Terminated

Recall details

Recalling firm

Biomet Microfixation, LLC

Reason for recall

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

Action taken

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

Status

Terminated

Product code

LZD

Quantity affected

42

Distribution

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

Date initiated

2014-10-17

Date posted

2014-12-16

Date terminated

2017-01-04

Location

Jacksonville, FL