FDA-Device2022-03-02Class II
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Nobel Biocare Usa Llc
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.
Sold states
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.
Affected count
702 pieces
Manufactured in
22715 Savi Ranch Pkwy, Yorba Linda, CA, United States
Products
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0658-2022Don't want to check this manually?
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