Device 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.
Z-0092-2018
Product summary
- Event
- Event 78140
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-0092-2018
Official wording
Reason: The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Code information: Lot Number 14GSM0440A
Distribution pattern: US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand
Derived failure modes
-
Unknown
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.