Reported Feb 26, 2020 · Terminated
Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if…
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?
- Abutment Screw Retrieval Instrument 3.0/NP -
- Product UsageThe instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new screw, a screw tap repair can be used. The instruments are intended for both simple and advanced treatments
- Lot codes and dates
- (01)07332747084085(10)73585 (01)07332747084085(10)73430 Catalog # 37503
- Amount recalled
- 233 units
This recall covers 24 products
The agency filed one notice per product. You are reading one of them; the other 23 are below.
11 more are in the archive.
Where it was sold
Why it was recalled
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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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