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LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6… recallZ-0591-2015 · Smith & Nephew, Inc. · initiated Nov 4, 2014

Class II Terminated All recalls posted in December 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0591-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 4, 2014
Posted by the FDA
Dec 12, 2014
Recalling firm
Smith & Nephew, Inc.
Quantity
23 units
Product code
JWH
FDA submissions
K060742
Distribution
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.

Product description

LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.

Code information (models, lots, serial numbers)

Lot Number 14EM23391

Other devices under the same FDA submission

36 devices cleared under K060742 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 69759).

Sources and updates

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