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Nobel Biocare
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Nobel Biocare and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-02-12FDA-DeviceClass II. 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
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.
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