PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: November 22, 2017 Initiated: September 14, 2017 #Z-0092-2018

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.

Details

Recalling Firm
Smith & Nephew, Inc.
Units Affected
10 units
Distribution
US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand
Location
Memphis, TN

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Smith & Nephew, Inc.. Units affected: 10 units.
Why was this product recalled? ▼
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 22, 2017. Severity: Moderate. Recall number: Z-0092-2018.

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