Recall Z-2237-2016— Nobel Biocare Usa Llc
Class II · Terminated
Class II FDA medical device recall by Nobel Biocare Usa Llc, initiated 2016-06-22, terminated 2016-09-06. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Incorrect top label on an implant package..
- Recalling firm
- Nobel Biocare Usa Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-22
- Terminated
- 2016-09-06
- Firm location
- Yorba Linda, CA, United States
Product 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 for recall
Incorrect top label on an implant package.
Data sourced from openFDA. This site is unofficial and independent of the FDA.