FDA Device recall Z-0092-2018
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…
- FDA Device
- Class II
- terminated
- Published 2017-11-22
On 2017-11-22 the FDA classified a Class II recall of 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… by Smith And Nephew, citing the Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0092-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-14 |
| Published | 2017-11-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smith And Nephew |
| Distribution | PR |
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
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Identifiers
| code_info | Lot Number 14GSM0440A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0092-2018%22
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