Device product
Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
Z-0512-2015
Product summary
- Event
- Event 69644
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42
- Official record key
device-enforcement:Z-0512-2015
Official wording
Reason: Laser etching on the parts is wider and deeper than the conditions previously validated.
Code information: Model 24-6645TI, Lot #s: 472580A, 472590B, 472580B, 472590A, 526030A, 526020A, 526020B, 526030B,
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.