Reported Jun 10, 2020 · Terminated
Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant…
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?
- Healing Abutment Conical Connection RP 0 3.6 x 5mm
- REF36644
- UDI07332747034462 -
- Product UsageDental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue
- Lot codes and dates
- Lot 13076845
- Amount recalled
- 234 pieces globally, of which 16 were sent to the US.
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Packaged dental implant healing abutments were found to contain the wrong size device.
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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