Reported Nov 26, 2014 · Terminated
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is…
Biomet Spine LLC.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomet Spine LLC. · 310 Interlocken Pkwy Ste 120 · Broomfield, CO · 80021-3464
Is this the product you have?
- LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case
- Product UsageThe 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
- Lot codes and dates
Lot numbers L532655L532690Product code 8503XXXX
- Amount recalled
- 120
Where it was sold
Why it was recalled
Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.
This product could cause temporary or reversible health problems — stop using it.
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