Nobel Biocare Usa Llc recalls NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R

Recall date

December 17, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0658-2022

FDA classification

Class II

Brand / firm

Nobel Biocare Usa Llc

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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