FDA recall Z-0658-2022

Nobel Biocare Usa Llc · Class II · device

Product

NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R

Reason for recall

Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.

Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, MA, ME, MI, MN, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA and WI. The countries of Canada, Mexico and Turkey.

Key facts

Status: Terminated
Initiation date: 2021-12-17
Report date: 2022-03-02
Termination date: 2024-10-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Yorba Linda, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0658-2022