Legion 71421776
Legion 71421776 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K041106 on 1 Jul 2004 and listed in FDA GUDID since 30 Aug 2015 (UDI-DI 03596010545343), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03596010545343 | Date30 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK041106 | Date1 Jul 2004 | StatusActive |
Official records
- AccessGUDID record 03596010545343
- FDA 510(k) database K041106
Across registries
- FDA 510(k) K041106 decided 1 Jul 2004 Active
- FDA GUDID UDI-DI 03596010545343 listed 30 Aug 2015 Listed
Recalls
-
- Terminated Z-0092-2018
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Timeline
- Cleared FDA 510(k) K041106
- Listed FDA GUDID 03596010545343
- Recall initiated FDA recalls Z-0092-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Legion
- Generic name
- Knee arthroplasty wedge
- Model / Ref / Catalog
- 71421776
- Primary DI / UDI-DI
- 03596010545343
- 510(k) Number
- FDA product code
- JWH
- GMDN term
- Knee arthroplasty wedge
- Device class
- Class II
- Regulation number
- 888.3560
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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