FDAClass IIDecember 14, 2016

LCS Complete Knee Revision System VVC Insert Product recall

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

Why was LCS Complete Knee Revision System VVC Insert Product 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LCS COMP VVC INS SM 22.5MM, Product Code: 129424122, Lot# C08294, GTIN: (01)10603295024484, Expiry: 31-Mar-2021

Product
LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1
Distribution
US Distribution in the state of TN
Recall date
December 14, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls