FDAFDA · Food and drugs·Recall number Z-0220-2015
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.
Published November 26, 2014 · Recall initiated: March 9, 2011
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
Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Biomet Spine LLC.
- Distributor
- US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,
- Lot
- Lot numbers L532655, L532690, Product code 8503XXXX
- 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.