Z-2566-2014 Class II Terminated
FDA device recall Z-2566-2014 was initiated by Biomet Microfixation, LLC on September 20, 2013 and is designated Class II. Reason for recall: Product mix occurred prior to final package and labeling process. The recall status is terminated (terminated October 3, 2014). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- September 10, 2014
- Initiation Date
- September 20, 2013
- Termination Date
- October 3, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
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.
Reason for Recall
Product mix occurred prior to final package and labeling process.
Distribution Pattern
Worldwide Distribution to Denmark only.
Code Information
Part #CP751506 Lot #478490