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.
Reported: July 27, 2016 Initiated: June 22, 2016 #Z-2237-2016
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.
Details
- Recalling Firm
- Nobel Biocare Usa Llc
- Units Affected
- 53 units total (33 units in US)
- Distribution
- Worldwide Distribution - US including OR, OH, NY and Internationally to Taiwan and Brazil Non US: Taiwan, SC
- Location
- Yorba Linda, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Nobel Biocare Usa Llc. Units affected: 53 units total (33 units in US).
Why was this product recalled? ▼
Incorrect top label on an implant package.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 27, 2016. Severity: Moderate. Recall number: Z-2237-2016.
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