Reported Jul 27, 2016 · Terminated
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered implants are root-form endosseous…
Nobel Biocare USA LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nobel Biocare Usa Llc · 22715/22725 Savi Ranch Pkwy · Yorba Linda, CA · 92887
Is this the product you have?
- 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.
- Lot codes and dates
- 13030677
- Amount recalled
- 53 units total (33 units in US)
Where it was sold
Why it was recalled
Incorrect top label on an implant package.
This product could cause temporary or reversible health problems — stop using it.
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