Z-2566-2014Class II

Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total...

Name: Z-2566-2014 Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total...
Creator: Biomet Microfixation, LLC
Published: 2013-09-20
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2013-09-20 / Terminated / root cause: labeling and UDI

FDA source

Biomet Microfixation, LLC began a recall of Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is... on 2013-09-20. FDA classified it as Class II and gives the reason as "Product mix occurred prior to final package and labeling process". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2566-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-20
Posted: 2014-09-02
Terminated: 2014-10-03
Recalling firm: Biomet Microfixation
Product: Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones by screws.
Product code: LZD Joint, Temporomandibular, Implant
Reason for recall: Product mix occurred prior to final package and labeling process.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Biomet Microfixation, Inc. sent an Urgent Medical Device Field Notice dated September 20, 2013 to its customer. The customer was instructed to: 1) Immedicately quarantine the device. 2) Discontinue use and return to Biomet Microfixation. 3) If the product was further distributed, the letter must be forwarded to the firm's customers. 4) A replacement device will be shipped priority upon completion. Questions related to this notice should be directed to 904-741-9448 or 904-239-6671. For questions regarding this recall call 904-741-4400.
Quantity in commerce: 1
Distribution: Worldwide Distribution to Denmark only.
Product codes and lots: Part #CP751506 Lot #478490

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2566-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2566-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-10	2014-09-02

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)