FDAClass IIJune 25, 2014

Biomet Spine recall

Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.

Why was Biomet Spine recalled?

The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.

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 14-501669; Lot Number 006731

Product
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
Recalling firm
Ebi, Llc
Quantity
32 units (30 domestic and 2 international)
Distribution
Worldwide Distribution - USA (nationwide) and the country The Netherlands.
Recall date
June 25, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls