—#131481

Product

LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 4, LEFT, REF 71425004, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K060742
Affected lot / code info: Lot Number 14FM05730

Why it was recalled

The stem taper on this device is undersized; the gauge point is not deep enough.

Root cause (FDA determination)

Process control

Action the firm took

The firm, Smith & Nephew, Inc., sent an "Urgent-Product Recall 1st Notification-Urgent" letter dated 11/4/ 2014 to its customers via E-mail on 11/4/2014. International distributors were notified on 11/4/2014 by Email. Non-responding consignees will be contacted on 11/25/2014 by original method. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect your inventory and locate any unused devices and immediately quarantine; complete and return the Inventory Return Certification Form via fax to: +1-901-566-7975, even if you do not have product to return; contact Smith & Nephew's Safety Affairs Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain return authorization (RA) number; and return affected product to Smith & Nephew, Attn: Global Field Actions, 3303 E Holmes Road, Memphis, TN 38118. If you have any questions, please contact the Group Director, Quality Assurance +1-901-399-1970.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) including states of: MI, MN, MO, OH, PA, IA, and TN; and Internationally to: SWITZERLAND; CANADA, COLOMBIA, GERMANY, Dubai, (UAE), THAILAND; SOUTH AFRICA, SOUTH KOREA; and SINGAPORE.

Timeline

Recall initiated: 2014-11-04
Posted by FDA: 2014-12-12
Terminated: 2019-08-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131481. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.