Class II — Potential Health Hazard

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

Locking Cortical Screw 3.5mmX38mm REF 8161-35-038 Recalled by Biomet, Inc. Due to 3.5mmx38mm Locking Cortical Screw, implants are being recalled...

Date: December 19, 2013
Company: Biomet, 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 Biomet, Inc. directly.

Affected Products

Locking Cortical Screw 3.5mmX38mm REF 8161-35-038

Quantity: 52

Why Was This Recalled?

3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.

Where Was This Sold?

This product was distributed to 15 states: AZ, CA, GA, IL, KY, MI, NH, NY, NC, OH, PA, SD, TX, UT, VA

Affected (15 states)Not affected

About Biomet, Inc.

Biomet, Inc. has 250 total recalls tracked by RecallDetector.

Related Recalls

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