FDA Medical Device Recalls (openFDA)
Biomet Microfixation, LLC: Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
- Recall number
- Z-0519-2015
- Recalling firm
- Biomet Microfixation, LLC
- Product
- Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
- Status
- Terminated
- Initiated
- 2014-10-17
- Posted
- 2014-12-16
- Terminated
- 2017-01-04
- Reason
- Laser etching on the parts is wider and deeper than the conditions previously validated.
- Root cause
- Software Design Change
- 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.
- Quantity
- 42
- Distribution
- Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
- Lot, serial or model codes
- Model 24-6556TI, Lot #s: 520240A, 520230A, 550400A, 550390B, 520230B, 520240B, 535400B, 550400B, 535400A, 535410A, 535410B, 550370A, 550370B, 550380A, 550380B, 550390A.
- 510(k) numbers
- not on file
- PMA numbers
- ["P020016"]
- Product code
- LZD
- Firm FEI
- 1032347
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28