Reported Feb 12, 2025 · Ongoing
. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP…
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 RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 30086207332747161748Lot Numbers: 12253672 12253673 Nobel Biocare N1 TiUltra TCC RP 4.0x11mm UDI-DI code: 07332747161748 30086307332747161755Lot Numbers: 12253448 12254209 Nobel Biocare N1 TiUltra TCC RP 4.0x13mm UDI-DI code: 07332747161755 — Lot Numbers: 12253620 12254213 - Amount recalled
- 1,558 units (90 units - U.S.)
Where it was sold
Why it was recalled
Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.
This product could cause temporary or reversible health problems — stop using it.
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