Drug recall
ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as…
FDA recall event 73208 · Class III · Collagen Matrix Inc
Key facts
| Event ID | 73208 |
|---|---|
| Recall numbers | Z-1173-2016 |
| Recalling firm | Collagen Matrix Inc |
| Product type | Devices |
| Products | ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -filling of defects after root resection… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine. |
| Initiation date | Nov 17, 2015 |
| Report date | Mar 23, 2016 |
| Termination date | May 10, 2018 |
| City | Franklin Lakes |
| State | NJ |
| Country | United States |
| FEI number | 3003300673 |
At a glance
- 1–9 Products in this recall
- 1–9 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: