FDAFDA · Food and drugs·Recall number Z-2284-2013
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Published October 2, 2013 · Recall initiated: August 23, 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
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Medtronic Xomed, Inc.
- Distributor
- Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
- Lot
- REF: 1150000 Lot: 0207029284
- 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.