Smith & Nephew, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0092-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 14, 2017

Date Posted: November 22, 2017

Recall Number: Z-0092-2018

Event ID: 78140

Reason for Recall:

The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.

Status: Terminated

Product Quantity: 10 units

Code Information:

Lot Number 14GSM0440A

Distribution Pattern:

US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand

Voluntary or Mandated:

Voluntary: Firm initiated