Device product
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
Z-0509-2015
Product summary
- Event
- Event 69644
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42
- Official record key
device-enforcement:Z-0509-2015
Official wording
Reason: Laser etching on the parts is wider and deeper than the conditions previously validated.
Code information: Model 01-6546TI, Lot #s: 531880B, 535890B, 531870A, 531870B, 531880A, 535890D, 535890A, 535890C.
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.