Class II — Potential Health Hazard

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

CORAIL Cementless Femoral Stem HA Coated Standard Size 11 Recalled by DePuy Orthopaedics, Inc. Due to Two lots of femoral stems were labeled as...

Date: June 21, 2018
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

CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511

Quantity: N/A

Why Was This Recalled?

Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.

Where Was This Sold?

This product was distributed to 14 states: AL, CA, CO, GA, IL, LA, ME, NH, NY, NC, OR, TX, UT, WA

Affected (14 states)Not affected

About DePuy Orthopaedics, Inc.

DePuy Orthopaedics, Inc. has 154 total recalls tracked by RecallDetector.

Related Recalls

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