Z-0658-2022 Class II Terminated
FDA device recall Z-0658-2022 was initiated by Nobel Biocare Usa Llc on Dec 17, 2021 and is designated Class II. 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… The recall status is terminated (terminated Oct 25, 2024). Affected quantity: 702 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 2, 2022
- Initiation Date
- Dec 17, 2021
- Termination Date
- Oct 25, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 702 pieces
Product Description
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
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 Pattern
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.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0658-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026