Z-0678-2019 Class II Terminated
FDA device recall Z-0678-2019 was initiated by Howmedica Osteonics Corp. on Nov 15, 2018 and is designated Class II. Reason for recall: Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19 The recall status is terminated (terminated Jun 18, 2020).
Recall Details
- Product Type
- Devices
- Report Date
- Jan 2, 2019
- Initiation Date
- Nov 15, 2018
- Termination Date
- Jun 18, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE
Reason for Recall
Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19
Distribution Pattern
CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV
Code Information
UDI - (01) 07613327064278 Lot Number: IC02595
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0678-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026