FDA Device recall Z-2967-2018
Foundation Modular Femoral Stem, Part Number, 220-10-110
- FDA Device
- Class II
- terminated
- Published 2018-09-12
On 2018-09-12 the FDA classified a Class II recall of Foundation Modular Femoral Stem, Part Number, 220-10-110 by Encore Medical, citing after receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2967-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-14 |
| Published | 2018-09-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Encore Medical |
| Distribution | AZ, MO, MS, NY, OK, UT |
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.
Identifiers
| code_info | All. Lots-866A1011, 866A1022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2967-2018%22
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