Z-0515-2015Class II

Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the...

Name: Z-0515-2015 Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the...
Creator: Biomet Microfixation, LLC
Published: 2014-10-17
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2014-10-17 / Terminated / root cause: software

FDA source

Biomet Microfixation, LLC began a recall of Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint on 2014-10-17. FDA classified it as Class II and gives the reason as "Laser etching on the parts is wider and deeper than the conditions previously validated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0515-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-17
Posted: 2014-12-16
Terminated: 2017-01-04
Recalling firm: Biomet Microfixation
Product: Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Product code: LZD Joint, Temporomandibular, Implant
Reason for recall: Laser etching on the parts is wider and deeper than the conditions previously validated.
Root cause tag: software
FDA 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 in commerce: 42
Distribution: Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
Product codes and lots: Model 01-6550TI, Lot #s: 531890A, 531890B, 531900A, 531900B, 544220B, 544230A, 544230B, 544200A, 544200B, 544210A, 544210B, 544220A.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0515-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0509-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0510-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0511-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0512-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0513-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0514-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0515-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0516-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0517-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0518-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0519-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0520-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0521-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08
Z-0522-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08

Product code LZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)