Drug recall
HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
FDA recall event 81641 · Class II · Howmedica Osteonics Corp.
Key facts
| Event ID | 81641 |
|---|---|
| Recall numbers | Z-0677-2019, Z-0678-2019 |
| Recalling firm | Howmedica Osteonics Corp. |
| Product type | Devices |
| Products | HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE, HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19, Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19 |
| Initiation date | Nov 15, 2018 |
| Report date | Jan 2, 2019 |
| Termination date | Jun 18, 2020 |
| City | Allendale |
| State | NJ |
| Country | United States |
| FEI number | 3004024955 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: