DePuy Orthopaedics, Inc. recalls LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.

Recall date

March 4, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1672-2015

FDA classification

Class II

Brand / firm

DePuy Orthopaedics, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.