FDAFDA · Food and drugs·Recall number Z-1996-2013
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 Usage: Orthopedic
Published August 28, 2013 · Recall initiated: July 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Smith & Nephew Inc
- Distributor
- International only: Germany, France, United Arab Emirates, and United Kingdom.
- Lot
- Lot Number 12LM03798
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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