NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Check against the official notice below — it lists the full affected range.
Nobel Biocare USA recalled 702 units of NobelReplace Conical Connection RP 4.3x11.5 mm implants (Catalog Number 36707) distributed worldwide to the U.S., Canada, Mexico, and Turkey. The recall was initiated due to 16 complaints that surgical drivers were not engaging properly with the implants. The company's investigation determined that an incorrect offset gauge may have been used during manufacturing of the affected implants.
This manufacturing issue could potentially result in surgical procedures being delayed or aborted. The affected implants are identified by lot numbers 13116495, 13116496, and 13116497. The source document does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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. Quantity: 702 pieces 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.