FDAClass IINovember 15, 2017

Cobalt MV Bone Cement 40GM recall

Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone…

Why was Cobalt MV Bone Cement 40GM recalled?

Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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: 507830, 871270, 959670

Product
Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone…
Recalling firm
Encore Medical, Lp
Quantity
840 units
Distribution
Nationwide Distribution
Recall date
November 15, 2017
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls