FDA Device recall Z-0678-2019
HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE
- FDA Device
- Class II
- terminated
- Published 2019-01-02
On 2019-01-02 the FDA classified a Class II recall of HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE by Howmedica Osteonics, citing incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0678-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-15 |
| Published | 2019-01-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Howmedica Osteonics |
| Distribution | CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI, WV |
Product
HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE
Reason
Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19
Identifiers
| code_info | UDI - (01) 07613327064278 Lot Number: IC02595 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0678-2019%22
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