Nobel Biocare N1 TiUltra TCC NP 3.5x13mm recall
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Why was Nobel Biocare N1 TiUltra TCC NP 3.5x13mm recalled?
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
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?
Catalog number: 300859 Lot numbers / UDI Codes: 12167337 / (01)07332747161717(10)12167337(11)210119(17)251218 12167830 / (01)07332747161717(10)12167830(11)210125(17)251224 12168184 / (01)07332747161717(10)12168184(11)210128(17)251227
- Product
- Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
- Recalling firm
- Nobel Biocare
- Quantity
- 347 devices
- Distribution
- U.S Nationwide.: AZ, CA, CT, FL, HI, NC, NY, OR, PA, TX, UT, and WI O.U.S.: Austria, Belgium, Canada, Germany, Spain, France, United Kingdom, Hungary, Iceland, Italy, Netherlands, Norway, Portugal, and Sweden
- Recall date
- August 31, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)