Reported Apr 22, 2015 · Terminated
NobelReplace CC RP 4.3x8mm, Article No. 36704.
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?
NobelReplace CC RP 4.3x8mmArticle No. 36704
- Lot codes and dates
Batch No. 130113781301137913011664
- Amount recalled
- 102 units
This recall covers 27 products
The agency filed one notice per product. You are reading one of them; the other 26 are below.
14 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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