DePuy Orthopaedics, Inc. recalls LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery

Recall date

November 8, 2016

Source

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

Recall number

Z-0703-2017

FDA classification

Class II

Brand / firm

DePuy Orthopaedics, Inc.

Sold / distributed

US Distribution in the state of TN

Why it was recalled

DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision System VVC Insert Small 22.5mm, due to the insert being manufactured outside of specifications, which prevents the insert from properly seating in the mating tibial tray.

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

What was recalled

LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery