Class II — Potential Health Hazard

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

Straumann Bone Level Implant Recalled by Straumann Manufacturing, Inc. Due to Misalignment with the Loxim transfer piece markings, the...

Date: July 14, 2016
Company: Straumann Manufacturing, Inc.
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 Straumann Manufacturing, Inc. directly.

Affected Products

Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510

Quantity: 70 pieces

Why Was This Recalled?

Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Straumann Manufacturing, Inc.

Straumann Manufacturing, Inc. has 11 total recalls tracked by RecallDetector.

Related Recalls

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