NobelReplace recallZ-0658-2022 · Nobel Biocare Usa Llc · initiated Dec 17, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nobel Biocare Usa Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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,
Recall details
- Recall number
- Z-0658-2022
- Status
- Terminated
- Initiated by the company
- Dec 17, 2021
- Recalling firm
- Nobel Biocare Usa Llc
- Quantity
- 702 pieces
- Product code
- DZE
- FDA submissions
- K073142
- 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.
Product description
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NobelReplace® 36707Nobel Biocare AB · IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall4,083 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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