FDA-Device2017-11-22Class II
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 collat
Smith & Nephew, Inc.
Hazard
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Sold states
US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand
Affected count
10 units
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0092-2018Don't want to check this manually?
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