FDAClass IIJanuary 2, 2019

HydroSet XT Injectable HA Bone Cement recall

HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE

Why was HydroSet XT Injectable HA Bone Cement recalled?

Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19

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?

UDI - (01)07613327064261 Lot Numbers: IC02565, ICO2570

Product
HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
Recalling firm
Howmedica Osteonics Corp.
Distribution
CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV
Recall date
January 2, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls