FDAClass IIMay 17, 2017

Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV recall: Sterility Concern

Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin

Why was Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV recalled?

Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the 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?

Model numbers: 402282 and 402282J - Cobalt HV Bone Cement 402438 - Cobalt MV Bone Cement 402283J - Cobalt HV Bone Cement With Gentamicin 402438 Lot: 507830 402282J Lot: 668140 402282 Lot: 508220 402283J Lot: 189780

Product
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Recalling firm
Zimmer Biomet, Inc.
Quantity
4238
Distribution
TX. Japan Mexico
Recall date
May 17, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls