Z-0658-2022Class II

NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R

Name: Z-0658-2022 NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Creator: Nobel Biocare Usa Llc
Published: 2021-12-17
License: https://open.fda.gov/license/

Nobel Biocare USA LLC / initiated 2021-12-17 / Terminated / root cause: manufacturing process

FDA source

Nobel Biocare Usa Llc began a recall of NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R on 2021-12-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0658-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-17
Posted: 2022-02-18
Terminated: 2024-10-25
Recalling firm: Nobel Biocare USA LLC
Product: NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Product code: DZE Implant, Endosseous, Root-Form
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.
Root cause tag: manufacturing process
FDA 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 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,
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0658-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0658-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-02	2022-02-18

Product code DZE

K073142Class IINobelreplace Hexagonal ImplantNobel Biocare USA, LLC / cleared 2008-01-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)