Recall Z-2566-2014— Biomet Microfixation, LLC
Class II · Terminated
Class II FDA medical device recall by Biomet Microfixation, LLC, initiated 2013-09-20, terminated 2014-10-03. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Product mix occurred prior to final package and labeling process..
- Recalling firm
- Biomet Microfixation, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-20
- Terminated
- 2014-10-03
- Firm location
- Jacksonville, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.