FDAFDA · Food and drugs·Recall number 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 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.
Published November 22, 2017 · Recall initiated: September 14, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand
- Lot
- Lot Number 14GSM0440A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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