Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Recalled by Nobel Biocare Due to Due to manufacturing issue (unintended by-product of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nobel Biocare directly.
Affected Products
. 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
Quantity: 1,558 units (90 units - U.S.)
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nobel Biocare
Nobel Biocare has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report