smith&nephew LEGION L-WEDGE — Class II medical device recall Z-0092-2018
Terminated recall by Smith & Nephew, Inc., reported 2017-11-22, distributed in PR. The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
| Recall number | Z-0092-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew, Inc., Memphis, TN, United States |
| Recall initiated | 2017-09-14 |
| Classified | 2017-11-16 |
| Reported by FDA | 2017-11-22 |
| Terminated | 2020-08-21 |
| Distributed | PR |
| Countries outside the US | BE, CH, EC, NL, TH |
| Quantity | 10 units |
| Lot numbers | 14GSM0440A |
| Model numbers | 71421733 |
Product
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use 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. The Revision Knee Components are for single use only and are intended for implantation with bone cement.
Reason for recall
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
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-0092-2018. 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.