LEGION — Class II medical device recall Z-2538-2019
Completed recall by Smith & Nephew, Inc., reported 2019-09-18. The affected products were inadvertently packaged with an incorrect screw component.
| Recall number | Z-2538-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2018-01-15 |
| Classified | 2019-09-12 |
| Reported by FDA | 2019-09-18 |
| Countries outside the US | CH, DE, FR, NL, NO |
| Quantity | 12 units |
| Model numbers | 71423432 |
Product
LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.
Reason for recall
The affected products were inadvertently packaged with an incorrect screw component.
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-2538-2019. 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.