NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
- Company
- Nobel Biocare Usa Llc
- Recall Initiated
- December 17, 2021
- Terminated
- October 25, 2024
- Recall Number
- Z-0658-2022
- Quantity
- 702 pieces
- Firm Location
- Yorba Linda, CA
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.
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
Root Cause
Under Investigation by firm
Action Taken
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 provided. 4. Ensure relevant staff members are informed of this recall, and if you further supplied or transferred any of the affected products to another facility or organization, let these facilities know of the recall and provide them with a copy of this notice. For questions, contact your local customer support representative,