DePuy Orthopaedics, Inc. recalls CORAIL HIGH OFFSET STEM Collarless SIZE 14

Recall date

July 12, 2017

Source

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

Recall number

Z-0594-2018

FDA classification

Class II

Brand / firm

DePuy Orthopaedics, Inc.

Sold / distributed

Nationally; US Consignees for this recall are the affected are US Distributors and US Medical Facilities (Hospitals/User Facilities) that may have purchased, used, or received the affected device.

Why it was recalled

Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).

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 HIGH OFFSET STEM Collarless SIZE 14