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Terminated

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.

FDA Recall Z-2566-2014 · Posted 2014-09-02

Recalling FirmBiomet Microfixation, LLC
Recall StatusTerminated
Product CodeLZD
Date Initiated2013-09-20
Date Terminated2014-10-03
Product Quantity1

Reason for Recall

Product mix occurred prior to final package and labeling process.

Firm 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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Worldwide Distribution to Denmark only.

Official Source

View FDA Recall →

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

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