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Genesis(R) Ii, Non-Porous Tibial Base, Size 5, Left, Qty:… recallZ-0130-2014 · Smith & Nephew Inc · initiated Oct 7, 2013

Class II Terminated All recalls posted in November 2013

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

Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

FDA root cause category: Process control

What the company is doing

Smith & Nephew sent an Urgent - Product Recall 1st Notification letter to all affected sales staff via email and FedEx on October 7, 2013. The hospital was notified by sales rep on October 9, 2013 and the notification letter was sent to the hospital via Fed Ex on October 11, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, discontinue use, quarantine affected products immediately and return to Smith & Nephew. Customers were asked to complete the attached Inventory Return Certification Form and fax to 901-566-7975.

Recall details

Recall number
Z-0130-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 7, 2013
Posted by the FDA
Nov 1, 2013
Recalling firm
Smith & Nephew Inc
Quantity
4 units
Product code
JWH
FDA submissions
K951987
Distribution
USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.

Product description

GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic

Code information (models, lots, serial numbers)

Batch No. 13GM11272

Other devices under the same FDA submission

137 devices cleared under K951987 — 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 66545).

Sources and updates

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