Reported Dec 11, 2013 · Terminated

GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew,…

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, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13
  • MM QTY(1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
Lot codes and dates
  • Batch No. 12GT20824
Amount recalled
45 pieces

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Why it was recalled

The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

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 20, 2019 · Data as of Sep 19, 6:07 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.