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Nobel Biocare Usa Llc recalls NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Recalled March 2, 2022 · FDA recall Z-0658-2022 · Nobel Biocare Usa
Hazard
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. · FDA Class II
Units
702 pieces
Sold at
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.
Description
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.
Product
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Manufacturer(s)
Nobel Biocare Usa Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →