Reported Feb 26, 2020 · Terminated
Drill Tapered WP 5x11.5 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone…
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?
- Drill Tapered WP 5x11.5
- mm Single-Pat - Product UsageDrills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement
- Lot codes and dates
- (01)07332747065572(10)73451 Catalog# 37086
- Amount recalled
- 59 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.
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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