Nobel Biocare: Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

Is my product affected?

Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

• UPC 07332747161717

Check against the official notice below — it lists the full affected range.

What happened

Nobel Biocare is recalling 347 Nobel Biocare N1 TiUltra TCC NP 3.5x13mm dental implants distributed nationwide in the U.S. and in 14 other countries due to the presence of a burr that may pose an aspiration risk to patients during surgical procedures. The affected devices have catalog number 300859 and one of three specific lot numbers: 12167337, 12167830, or 12168184.

The record does not specify a remedy or what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.

Details from the source

Reason for recall: Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure. 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 Quantity: 347 devices Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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