Device 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.
Z-2566-2014
Product summary
- Event
- Event 67547
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-2566-2014
Official wording
Reason: Product mix occurred prior to final package and labeling process.
Code information: Part #CP751506 Lot #478490
Distribution pattern: Worldwide Distribution to Denmark only.
Derived failure modes
-
Unknown
Product mix occurred prior to final package and labeling process.