FDAClass IIDecember 26, 2012

Biomet Polaris 5.5 Button Lock Screw Inserter recall

Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178

Why was Biomet Polaris 5.5 Button Lock Screw Inserter recalled?

Broken screw insertor hardness was measured and found to be below the acceptable limits.

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 540199, 540199-1

Product
Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
Recalling firm
Ebi, Llc
Quantity
15 units
Distribution
Nationwide Distribution, including the states of MO, TX, and IN.
Recall date
December 26, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls