Foundation Modular Femoral Stem recall: Labeling Error
Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as…
Why was Foundation Modular Femoral Stem recalled?
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All. Lots-866A1011, 866A1022
- Product
- Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as…
- Recalling firm
- Encore Medical, Lp
- Quantity
- 12
- Distribution
- U.S. Distribution to states of: AZ, MO, MS, NY, OK, and UT; internationally to: Japan.
- Recall date
- September 12, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)