Nobel Biocare Usa Llc Recall 89465
Description: NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Nobel Biocare Usa Llc Recall 89465 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0658-2022 |
| Event ID | 89465 |
| Event Description | NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R |
| Product Type | Devices |
| 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 |
| Recall Reason | 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. |
| Device Classification | 20220302 |
| Device 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 |
| Center Classification Date | 20220218 |
| Recall Initiation Date | 20211217 |
| Recalling Firm | Nobel Biocare Usa Llc |
| Initial Notification | Letter |
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