DePuy Orthopaedics, Inc. recalls CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical…

Recall date

September 21, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1129-2019

FDA classification

Class II

Brand / firm

DePuy Orthopaedics, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide Distributed to accounts in AL AZ CA CO FL GA HI IA IL IN KY LA MA MD ME MI MN MS NC ND NH NJ NV NY OH OR PA SC TN TX UT VA WA, and WI. International distribution worldwide.

Why it was recalled

There is the potential for debris/material to be found behind the O-rings in the neck trials.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.