Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R Recalled by Nobel Biocare Usa Llc Due to Due to 16 complaints related to drivers not...

Date: December 17, 2021
Company: Nobel Biocare Usa Llc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nobel Biocare Usa Llc directly.

Affected Products

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

Quantity: 702 pieces

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Nobel Biocare Usa Llc

Nobel Biocare Usa Llc has 66 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report