NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
FDA Recall Z-0658-2022 · Posted None
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Recalling FirmNobel Biocare Usa Llc
Recall StatusTerminated
Product CodeDZE
Date Initiated2021-12-17
Date Terminated2024-10-25
Product Quantity702 pieces
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.
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 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,
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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