Device product
Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
Z-0517-2015
Product summary
- Event
- Event 69644
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42
- Official record key
device-enforcement:Z-0517-2015
Official wording
Reason: Laser etching on the parts is wider and deeper than the conditions previously validated.
Code information: Model 24-6650TI, Lot #s: 518480B, 518480A, 525970A, 525970B, 525980B, 518490A, 526070A, 525990A, 525990B, 526060A, 526060B, 526070B, 525980A, 550330A, 550330B, 550340A, 550340B, 550350A, 550360A, 550360B, 518490B, 525960A, 525960B,
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.