Recall Z-0658-2022— Nobel Biocare Usa Llc

Name: FDA recall Z-0658-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-17

Class II · Terminated

Class II FDA medical device recall by Nobel Biocare Usa Llc, initiated 2021-12-17, terminated 2024-10-25. It names one FDA 510(k) clearance: K073142. Product: NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R. Reason: 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..

Recalling firm: Nobel Biocare Usa Llc
Classification: Class II
Status: Terminated
Initiated: 2021-12-17
Terminated: 2024-10-25
Firm location: Yorba Linda, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K073142 — NOBELREPLACE HEXAGONAL IMPLANTNobel Biocare USA, LLC·cleared 2008-01-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.