FDAFDA · Food and drugs·Recall number Z-2136-2013
SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
Published September 11, 2013 · Recall initiated: June 24, 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 firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Stelkast Co
- Distributor
- Nationwide Distribution including TX, VA, OK, and PA
- Lot
- Part number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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