Foundation Modular Femoral Stem — Class II medical device recall Z-2967-2018
Terminated recall by Encore Medical, Lp, reported 2018-09-12, distributed in AZ, MO, MS, NY, OK, UT. After receipt of a product complaint for the labeling, it was determined that this device does not have FDA cl
| Recall number | Z-2967-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, Lp, Austin, TX, United States |
| Recall initiated | 2018-05-14 |
| Classified | 2018-08-31 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2020-08-17 |
| Distributed | AZ, MO, MS, NY, OK, UT |
| Countries outside the US | JP |
| Quantity | 12 |
| Reason classes | labeling |
| Lot numbers | 866A1011, 866A1022 |
| Model numbers | 220-10-110 |
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 for recall
After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2967-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.