LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
FDA Recall Z-0591-2015 · Posted 2014-12-12
Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2014-11-04
Date Terminated2019-08-22
Product Quantity23 units
Reason for Recall
The stem taper on this device is undersized; the gauge point is not deep enough.
Firm Action
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 [email protected] 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.
Root Cause
Process control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.