Device Recall LCS Complete Knee Revision System VVC Insert 의 리콜

Recall

75608

Class 2

Z-0703-2017

2016-11-08

2016-12-03

Terminated

United States

2017-06-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150904

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.

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.