Drug recall
Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT…
FDA recall event 88586 · Class II · Medtronic Xomed, Inc.
Key facts
| Event ID | 88586 |
|---|---|
| Recall numbers | Z-0156-2022, Z-0157-2022, Z-0158-2022 |
| Recalling firm | Medtronic Xomed, Inc. |
| Product type | Devices |
| Products | Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following…, Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following…, Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the Midas Rex Microsaw and Triton System with the following… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There was an increase in complaints related to tip breaks and wobble/vibration. |
| Initiation date | Aug 31, 2021 |
| Report date | Oct 27, 2021 |
| City | Jacksonville |
| State | FL |
| Country | United States |
| FEI number | 1045254 |
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: