FDA recall Z-1851-2020

Nobel Biocare Usa Llc · Class II · device

Product

NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.

Reason for recall

The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).

Distribution

International distribution - the country Russia only.

Key facts

Status: Terminated
Initiation date: 2019-08-28
Report date: 2020-05-13
Termination date: 2021-04-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Yorba Linda, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1851-2020