CLASS II Device recall · Reported 10 Sep 2014 · FDA Enforcement Report
Temporomandibular Joint (TMJ) Patient Matched Left Fossa recalled
Biomet Microfixation is recalling Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total. The recall was initiated on 20 Sep 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2566-2014
- FDA event ID
- 67547
- Recalling firm
- Biomet Microfixation, Jacksonville, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Sep 2013
- FDA classified
- 2 Sep 2014
- Reported
- 10 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 20 Sep 2013 | Recall initiated by company | |
| 2 Sep 2014 | Classified by FDA | +347 days |
| 10 Sep 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product mix occurred prior to final package and labeling process.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution to Denmark only.
Questions about this recall
Why was it recalled?
Product mix occurred prior to final package and labeling process.
Which lots are affected?
Part #CP751506 Lot #478490
Where was it sold?
Worldwide Distribution to Denmark only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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