Z-0092-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 22, 2017
- Initiation Date
- September 14, 2017
- Termination Date
- August 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
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 for Recall
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Distribution Pattern
US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand
Code Information
Lot Number 14GSM0440A