Reported May 13, 2020 · Terminated
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI…
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 Savi Ranch Pkwy · Yorba Linda, CA · 92887-4609
Is this the product you have?
3 of 3 products
| Model / number | Barcodes | Product as published |
|---|---|---|
| — | NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant) | |
37965 | — | |
| — | 07332747091441 | UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function. |
- Lot codes and dates
- Lot12129104
- Amount recalled
- 228 pieces
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Why it was recalled
The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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