FDA Medical Device Recalls (openFDA)
DePuy Orthopaedics, Inc.: LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
- Recall number
- Z-0703-2017
- Recalling firm
- DePuy Orthopaedics, Inc.
- Product
- LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
- Status
- Terminated
- Initiated
- 2016-11-08
- Posted
- 2016-12-03
- Terminated
- 2017-06-05
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- DePuy Orthopaedics, Inc. initiated a voluntary recall on 11/8/2016 via letter mailed to the customer. Only one device was distributed in the U.S., and this was removed from the hospital on 21-Oct-2016. This recall does not affect any other lots of the LCS Complete Knee Revision System VVC Insert Small 22.5mm devices. The recall notice provides instructions for notifying the medical facility that received, used, or purchased the affected lot of the LCS Complete Knee Revision System VVC Insert Small 22.5mm. The purpose of this device recall is to notify medical professionals of the possible effects of using the affected device and to communicate that there are no recalled devices distributed at this time. The customer was asked to do the following: Complete the Reconciliation Form and return to your DePuy Orthopaedics Sales Consultant or fax to 574-371-4939 or email to DPYUS-JointReconFieldActions@its.jnj.com within five (5) business-days of this notice. " Retain a copy of the completed Reconciliation Form and this notice in your files. " Forward this notice to others in your facility that need to be informed. Effectiveness will be determined by the return of one US Medical Facility Reconciliation Form. For questions about device recall information provided, please contact Kim Earle, Senior Recall Coordinator, at 574-371-4917 or kearle@its.jnj.com or DPYUS-JointReconFieldActions@its.jnj.com.
- Quantity
- 1
- Distribution
- US Distribution in the state of TN
- Lot, serial or model codes
- LCS COMP VVC INS SM 22.5MM, Product Code: 129424122, Lot# C08294, GTIN: (01)10603295024484, Expiry: 31-Mar-2021
- 510(k) numbers
- not on file
- PMA numbers
- ["P830055"]
- Product code
- NJL
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28