Recall Z-0658-2022 ยท DZE Implant, Endosseous, Root-Form
Nobel Biocare Usa Llc
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
| Date | Dec 17, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On 01/12/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via UPS to customers informing them that specific batches/lots of devices, the dimensions of the hexagon connection part are potentially not fully conforming to specification and may not fully engage in the implant. Customers are instructed to: 1. Inspect their stock and quarantine all affected devices. 2. Complete the Customer Acknowledgement Form and return to the Recalling Firm via email or fax within 5 days of receipt of this notice. 3. Return all affected stock on hand to the Recalling Firm using the shipping label pro |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073142 | NOBELREPLACE HEXAGONAL IMPLANT Nobel Biocare USA, LLC, Jan 11, 2008 |