—#147034

Product

LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hinge Knee System is for cemented use only.

FDA product code: KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K081111
Affected lot / code info: Lot Code: 15LM08798

Why it was recalled

The surface inside of the femoral component, where cement is applied for adhesion, is below specification.

Root cause (FDA determination)

Process control

Action the firm took

The firm sent an Urgent Product Recall letter dated May 26, 2016 to customers, via email and FedEx Overnight delivery . The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Inspect inventory and locate any unused devices from the listed product and batch numbers, and quarantine them immediately. 2. Complete the Inventory Return Certification Form on the following page, indicating the quantities that need to be returned. If you do not have product to return, place an x in the column No Product to Return. Include your contact information in the spaces provided at the bottom of the form. 3. Contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return. 4. Return any affected product to the address listed on the Inventory Return Certification Form. Indicate the RA number on your return shipment.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.

Timeline

Recall initiated: 2016-05-26
Terminated: 2019-08-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147034. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.