FDAClass IIMarch 27, 2013

Biomet Spine Polaris 5.5 Button Lock Screw Inserter recall

Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal…

Why was Biomet Spine Polaris 5.5 Button Lock Screw Inserter recalled?

Increased risk of failure at the driver tip during screw insertion or removal.

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?

Catalog Number 14-500178. Lot numbers: 543619, 543853, 543853-1, 543853-2, 544233, 544234-1, 546613 and 546613-1.

Product
Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal…
Recalling firm
Ebi, Llc
Quantity
59 units.
Distribution
Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.
Recall date
March 27, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls