FDAClass IIDecember 4, 2013

Vertebroplasty Needle Kit recall

Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.

Why was Vertebroplasty Needle Kit recalled?

Complaints were received of inconsistencies in the expiration dates shown on the packaging of the Vertebroplasty Needle Kit 10g Diamond Tip device.

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?

Part No. 03.702.218S, Lot No. AJM838X

Product
Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.
Recalling firm
Synthes USA HQ, Inc.
Quantity
40
Distribution
Nationwide Distribution including IN, MT, HI, and FL.
Recall date
December 4, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls