LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.

FDA device recall Z-1673-2015 · posted 2015-05-26 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.

Action taken

On 3/4/2015, URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System and on 3/19/2015 REVISED URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System (Revised) notifications were sent to the affected distributors and medical professionals. All distributors were notified via electronic mail, and all medical professionals with affected inventory were also notified by distributor or Sales Consultant via in person delivery or mail or electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. to 5 p.m. EDT).

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

NJL

Quantity affected

28,732

Distribution

Worldwide Distribution-US (nationwide) and the countries of CANADA, AUSTRALIA, AUSTRIA, BELGIUM, UK, FRANCE, GREECE, IRELAND, ISRAEL, ITALY, KOREA, LUXEMBOURG, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORW

Date initiated

2015-03-04

Date posted

2015-05-26

Date terminated

2015-10-30

Location

Warsaw, IN