FDA Device recall Z-0537-2015
Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold unde…
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold unde… by Instrumed International, citing the reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0537-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-08 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Instrumed International |
| Distribution | US |
Product
Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.
Reason
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
Identifiers
| code_info | 1) Instrumed Product Name: Bunnell Drill, 5 3/4", w/ chuck key; Instrumed Product Number: 590-05389; Trade Name: Boss I…1) Instrumed Product Name: Bunnell Drill, 5 3/4", w/ chuck key; Instrumed Product Number: 590-05389; Trade Name: Boss Instruments; Boss Instruments Product Name: Bunnell Drill, 5 3/4"; Boss Instruments Item Number: 74-1240; Lot Numbers: 030511, 060110, 070311. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0537-2015%22
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