Z-0520-2015 Class II Terminated
FDA device recall Z-0520-2015 was initiated by Biomet Microfixation, LLC on October 17, 2014 and is designated Class II. Reason for recall: Laser etching on the parts is wider and deeper than the conditions previously validated. The recall status is terminated (terminated January 4, 2017). Affected quantity: 42.
Recall Details
- Product Type
- Devices
- Report Date
- December 17, 2014
- Initiation Date
- October 17, 2014
- Termination Date
- January 4, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42
Product Description
Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
Reason for Recall
Laser etching on the parts is wider and deeper than the conditions previously validated.
Distribution Pattern
Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
Code Information
Model 24-6555TI, Lot #s: 525210B, 525200A, 525200B, 525210A.