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.
Reported: September 12, 2018 Initiated: May 14, 2018 #Z-2967-2018
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.
Details
- Recalling Firm
- Encore Medical, Lp
- Units Affected
- 12
- Distribution
- U.S. Distribution to states of: AZ, MO, MS, NY, OK, and UT; internationally to: Japan.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Encore Medical, Lp. Units affected: 12.
Why was this product recalled? ▼
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 12, 2018. Severity: Moderate. Recall number: Z-2967-2018.
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