Reported Aug 28, 2013 · Terminated

GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF…

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 CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490
  • Product UsageOrthopedic
Lot codes and dates
  • Lot Number 12LM03798
Amount recalled
9 units

Why it was recalled

The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).

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 19, 2019 · Data as of Sep 19, 4:48 PM UTC

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