Reported Nov 13, 2013 · Terminated

GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic

Smith & Nephew Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Smith & Nephew Inc · 1450 E. Brooks Rd · Memphis, TN · 38116

Is this the product you have?

  • GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT
  • QTY
    • (1)
    • REF 71420188
  • Product Usageorthopaedic
Lot codes and dates
  • Batch No. 13GM09505
Amount recalled
4 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 23, 2016 · Data as of Sep 19, 4:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.