Recall Z-0703-2017 ยท NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
DePuy Orthopaedics, Inc.
LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
| Date | Dec 3, 2016 (initiated Nov 8, 2016) |
| Status | Terminated |
| 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 ef |
| Quantity | 1 |
| Distribution | US Distribution in the state of TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.