FDAClass IINovember 26, 2014

LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within recall

LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion…

Why was LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers L532655, L532690, Product code 8503XXXX

Product
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion…
Recalling firm
Biomet Spine LLC.
Quantity
120
Distribution
US Nationwide Distribution in the states of California, Indiana, Louisiana, and Texas,
Recall date
November 26, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls