Nobel Biocare Usa Llc: Medical Device Recall in 2022 - (Recall #: Z-0658-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 17, 2021

Date Posted: March 2, 2022

Recall Number: Z-0658-2022

Event ID: 89465

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.

Status: Terminated

Product Quantity: 702 pieces

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated