Medical device recalls Moderate risk

Howmedica Osteonics Corp. recalls HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE

Recall date
November 15, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0678-2019
FDA classification
Class II
Brand / firm
Howmedica Osteonics Corp.
Sold / distributed
CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE

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