FDAFDA · Food and drugs·Recall number Z-2633-2016
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,
Published August 31, 2016 · Recall initiated: July 18, 2016
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 alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Distributor
- AR, MN,MA
- Lot
- P239157
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.