Dental implants recalled for manufacturing defect affecting sterile packaging
Nobel Biocare recalled N1 TiUltra TCC dental implants due to a manufacturing defect that may puncture the sterile blister packaging. The defect is a sharp pin created during injection molding that could compromise product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a manufacturing defect that may compromise the sterile barrier of dental implants. Dental implants are high-risk products due to direct bone contact, and a breached sterile barrier poses contamination risk. No illnesses or injuries have been reported, so the hazard remains theoretical.
Plain-English summary
Nobel Biocare is recalling its N1 TiUltra TCC dental implants (available in three sizes: 4.0x9mm, 4.0x11mm, and 4.0x13mm). These are endosseous dental implants intended to be placed in bone to anchor or support dental prostheses.
The implants are being recalled due to a manufacturing defect from the injection molding process. A sharp pin generated during manufacturing may puncture the sterile blister packaging, breaching the sterile barrier that protects the implant.
The recall affects approximately 1,558 implant units worldwide, with 90 units distributed in the United States across California, Florida, Illinois, Massachusetts, New Jersey, New York, Ohio, Pennsylvania, Utah, Virginia, and Washington.
Patients and healthcare providers who have received these implants should contact Nobel Biocare. No injuries or illnesses related to this defect have been reported to the FDA.
The recalled product
- Product
- . 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…
- Manufacturer
- Nobel Biocare
- Category
- Medical Device — Dental Implants
Distribution
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