Recall Z-1673-2015— DePuy Orthopaedics, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2015-03-04, terminated 2015-10-30. FDA's recall record names no specific 510(k) clearance for this event. Product: LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.. Reason: 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..
- Recalling firm
- DePuy Orthopaedics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-04
- Terminated
- 2015-10-30
- Firm location
- Warsaw, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.