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Recall Observatory FDA recall evidence

Device product

HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE

Z-0678-2019

November 15, 2018

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 81641
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-0678-2019

Official wording

Reason: Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19

Code information: UDI - (01) 07613327064278 Lot Number: IC02595

Distribution pattern: CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19