LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
Reported: June 3, 2015 Initiated: March 4, 2015 #Z-1673-2015
Product Description
LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
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.
Details
- Recalling Firm
- DePuy Orthopaedics, Inc.
- Units 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, NORWAY, SOUTH AFRICA, SWITZERLAND, THAILAND.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.. Recalled by DePuy Orthopaedics, Inc.. Units affected: 28,732.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 3, 2015. Severity: Moderate. Recall number: Z-1673-2015.
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