medical Class II Updated 2022-03-02

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

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
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