Drug recall
Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and…
FDA recall event 73140 · Class II · Biomet, Inc.
Key facts
| Event ID | 73140 |
|---|---|
| Recall numbers | Z-1082-2016 |
| Recalling firm | Biomet, Inc. |
| Product type | Devices |
| Products | Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the product. If… |
| Initiation date | Jan 29, 2016 |
| Report date | Mar 16, 2016 |
| Termination date | Sep 5, 2017 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1825034 |
At a glance
- 1–9 Products in this recall
- None 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: