Device product
Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
Z-0519-2015
Product summary
- Event
- Event 69644
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42
- Official record key
device-enforcement:Z-0519-2015
Official wording
Reason: Laser etching on the parts is wider and deeper than the conditions previously validated.
Code information: Model 24-6556TI, Lot #s: 520240A, 520230A, 550400A, 550390B, 520230B, 520240B, 535400B, 550400B, 535400A, 535410A, 535410B, 550370A, 550370B, 550380A, 550380B, 550390A.
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.