LEGION PS High Flex XLPE size 5-6 9mm Articular Insert — Class II medical device recall Z-1507-2020
Terminated recall by Smith & Nephew, Inc., reported 2020-03-25, distributed in CA, IL, LA, MI, NC, NM, OR, PA…. LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
| Recall number | Z-1507-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2019-12-19 |
| Classified | 2020-03-17 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2024-09-04 |
| Distributed | CA, IL, LA, MI, NC, NM, OR, PA, PR, TN, TX |
| Countries outside the US | IT, NL, RO |
| Quantity | 29 units |
| Lot numbers | 19FM12500 |
Product
LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
Reason for recall
LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
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-1507-2020. 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.