Device product
Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Z-0515-2015
Product summary
- Event
- Event 69644
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42
- Official record key
device-enforcement:Z-0515-2015
Official wording
Reason: Laser etching on the parts is wider and deeper than the conditions previously validated.
Code information: Model 01-6550TI, Lot #s: 531890A, 531890B, 531900A, 531900B, 544220B, 544230A, 544230B, 544200A, 544200B, 544210A, 544210B, 544220A.
Distribution pattern: Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom.
Derived failure modes
-
Unknown
Laser etching on the parts is wider and deeper than the conditions previously validated.