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 (CC) PMC RP 4.3x10mm Recalled by NOBEL BIOCARE SERVICES AG Due to Dental implant cap label may incorrectly indicate implant...

Date: July 20, 2020
Company: NOBEL BIOCARE SERVICES AG
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 SERVICES AG directly.

Affected Products

NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.

Quantity: 188

Why Was This Recalled?

Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, the implant may damage the inferior alveolar nerve canal or perforate a small artery requiring immediate implant removal.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About NOBEL BIOCARE SERVICES AG

NOBEL BIOCARE SERVICES AG has 1 total recall tracked by RecallDetector.

Related Recalls

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