Recall Z-2967-2018— Encore Medical, Lp
Class II · Terminated
Class II FDA medical device recall by Encore Medical, Lp, initiated 2018-05-14, terminated 2020-08-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.. Reason: After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance..
- Recalling firm
- Encore Medical, Lp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-14
- Terminated
- 2020-08-17
- Firm location
- Austin, TX, United States
Product description
Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.
Reason for recall
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.