Class II — Potential Health Hazard

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

ACTIS Flex Reamers SZ 0/1 Recalled by Depuy Orthopaedics Inc. Due to DePuy Orthopaedics, Inc. is issuing a voluntary recall...

Date: October 25, 2016
Company: Depuy Orthopaedics 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 Depuy Orthopaedics Inc. directly.

Affected Products

ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam protectors, with label and IFU

Quantity: 137

Why Was This Recalled?

DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.

Where Was This Sold?

This product was distributed to 11 states: CA, KY, LA, ME, MD, NH, NY, NC, TX, VA, WA

Affected (11 states)Not affected

About Depuy Orthopaedics Inc.

Depuy Orthopaedics Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

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