Device product
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous implants intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function.
Z-2237-2016
Product summary
- Event
- Event 74486
- Status
- Terminated
- Classification
- Class II
- Quantity
- 53 units total (33 units in US)
- Official record key
device-enforcement:Z-2237-2016
Official wording
Reason: Incorrect top label on an implant package.
Code information: 13030677
Distribution pattern: Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC
Derived failure modes
-
Unknown
Incorrect top label on an implant package.