Instrumed International, Inc. Recall: McKenzie enlarging burrs are bone cutting and drilli
Instrumed International, Inc. Recall: McKenzie enlarging burrs are bone cutting and drilli is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Instrumed International, Inc.; Product: McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on
| Recalling firm | Instrumed International, Inc. |
|---|---|
| Product | McKenzie enlarging burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names. |
| Reason for recall | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA. |
| Recall initiated | 20140908 |
| Recall number | Z-0547-2015 |
| Category | device |
| State | IL |
| Country | United States |
$29/mo
Try RecallGuard →