FDA Enforcement
Class II
Terminated
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.
Recall: Z-2237-2016
·
Reported July 27, 2016
Enforcement
- Recall Number
- Z-2237-2016
- Event ID
- 74486
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Nobel Biocare Usa Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 27, 2016
- Initiation Date
- June 22, 2016
- Classification Date
- July 19, 2016
- Termination Date
- September 6, 2016
- Address
- 22715/22725 Savi Ranch Pkwy, N/A, Yorba Linda, CA, 92887, United States
Description
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.
Reason
Incorrect top label on an implant package.
Code Info
13030677
Distribution
Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC
Quantity
53 units total (33 units in US)