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Recall Observatory FDA recall evidence

Device product

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

Z-0703-2017

November 08, 2016

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 75608
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-0703-2017

Official wording

Reason: 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.

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

Distribution pattern: US Distribution in the state of TN

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.