FDAFDA · Food and drugs·Recall number Z-2566-2014
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.
Published September 10, 2014 · Recall initiated: September 20, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product mix occurred prior to final package and labeling process.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Biomet Microfixation, LLC
- Distributor
- Worldwide Distribution to Denmark only.
- Lot
- Part #CP751506 Lot #478490
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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