LCS COMPLETE recallZ-0703-2017 · DePuy Orthopaedics, Inc. · initiated Nov 8, 2016
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DePuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected] 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 [email protected] or [email protected].
Recall details
- Recall number
- Z-0703-2017
- Status
- Terminated
- Initiated by the company
- Nov 8, 2016
- Posted by the FDA
- Dec 3, 2016
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 1
- Product code
- NJL
- FDA submissions
- P830055
- Distribution
- US Distribution in the state of TN
Product description
LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
Code information (models, lots, serial numbers)
LCS COMP VVC INS SM 22.5MM, Product Code: 129424122, Lot# C08294, GTIN: (01)10603295024484, Expiry: 31-Mar-2021
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LCS COMPLETE 1294-24-122Depuy Orthopaedics, Inc. · Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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