. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel recall: Sterility Concern
. 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…
Why was . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Nobel Biocare N1 TiUltra TCC RP 4.0x 9mm Catalog Number: 300861 UDI-DI code: 07332747161731 Lot Numbers: 12253672 12253673 Nobel Biocare N1 TiUltra TCC RP 4.0x11mm Catalog Number: 300862 UDI-DI code: 07332747161748 Lot Numbers: 12253448 12254209 Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Catalog Number: 300863 UDI-DI code: 07332747161755 Lot Numbers: 12253620 12254213
- 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…
- Recalling firm
- Nobel Biocare
- Quantity
- 1,558 units (90 units - U.S.)
- Distribution
- U.S. Nationwide distribution in the states of CA, FL, IL, MA, NJ, NY, OH, PA, UT, VA and WA.
- Recall date
- February 12, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)