DePuy Orthopaedics, Inc. recalls DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthop…

Recall date

January 6, 2017

Source

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

Recall number

Z-2317-2017

FDA classification

Class II

Brand / firm

DePuy Orthopaedics, Inc.

Sold / distributed

Nationwide Distribution to: AZ CA IA IL IN LA MA MD ME MI MN PA VA

Why it was recalled

Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured.

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

What was recalled

DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures