Recall Z-0515-2015— Biomet Microfixation, LLC
Class II · Terminated
Class II FDA medical device recall by Biomet Microfixation, LLC, initiated 2014-10-17, terminated 2017-01-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint. Reason: Laser etching on the parts is wider and deeper than the conditions previously validated..
- Recalling firm
- Biomet Microfixation, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-17
- Terminated
- 2017-01-04
- Firm location
- Jacksonville, FL, United States
Product description
Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Reason for recall
Laser etching on the parts is wider and deeper than the conditions previously validated.
Data sourced from openFDA. This site is unofficial and independent of the FDA.