smith&nephew LEGION — Class II medical device recall Z-1907-2018
Terminated recall by Smith & Nephew, Inc., reported 2018-05-30. The affected products were inadvertently packaged with the inner packaging pouch being sealed together with th
| Recall number | Z-1907-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2018-03-30 |
| Classified | 2018-05-22 |
| Reported by FDA | 2018-05-30 |
| Terminated | 2019-08-21 |
| Countries outside the US | AU, CA, DE, GB, IT, MY, SG |
| Quantity | 47 units |
| Lot numbers | 08BM09288, 12EM05884, 12EM07720 |
| Model numbers | 71453101DESIGNED |
Product
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
Reason for recall
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
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-1907-2018. 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.