Drug recall
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.
FDA recall event 80845 · Class II · Orthosensor, Inc.
Key facts
| Event ID | 80845 |
|---|---|
| Recall numbers | Z-0082-2019, Z-0083-2019, Z-0084-2019, Z-0085-2019, Z-0086-2019, Z-0087-2019 |
| Recalling firm | Orthosensor, Inc. |
| Product type | Devices |
| Products | OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L., OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R., OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L., OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R., OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L. and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. |
| Initiation date | Jul 12, 2018 |
| Report date | Oct 17, 2018 |
| Termination date | Jun 27, 2019 |
| City | Dania |
| State | FL |
| Country | United States |
| FEI number | 3008592715 |
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: