Reported Aug 31, 2022 · Ongoing
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Nobel Biocare
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 · Vastra Hamngatan 1 · Goteborg · N/A
Is this the product you have?
- Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
- Lot codes and dates
- Catalog number300859
- Lot numbers / UDI Codes12167337 / (01)07332747161717(10)12167337(11)210119(17)251218 12167830 / (01)07332747161717(10)12167830(11)210125(17)251224 12168184 / (01)07332747161717(10)12168184(11)210128(17)251227
- Amount recalled
- 347 devices
Where it was sold
Why it was recalled
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
This product could cause temporary or reversible health problems — stop using it.
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