Drug recall
Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone…
FDA recall event 68651 · Class II · Biomet, Inc.
Key facts
| Event ID | 68651 |
|---|---|
| Recall numbers | Z-2212-2014 |
| Recalling firm | Biomet, Inc. |
| Product type | Devices |
| Products | Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck. |
| Initiation date | Jun 23, 2014 |
| Report date | Aug 20, 2014 |
| Termination date | Jul 14, 2015 |
| 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: