NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
FDA Recall #Z-0658-2022 — Class II — December 17, 2021
Product Description
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.
Recalling Firm
Nobel Biocare Usa Llc — Yorba Linda, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
702 pieces
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.
Code Information
Catalog Number: 36707 UDI Code: (01)07332747160529(10)13116495(11)210720(17)260618; (01)07332747160529(10)13116496(11)210720(17)260618; (01)07332747160529(10)13116497(11)210720(17)260618; Lot Numbers: 13116495, 13116496, 13116497
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated