FDA Device recall Z-0545-2015
McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold und…
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold und… by Instrumed International, citing the reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet….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-0545-2015 |
| 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
McKenzie Perforator Drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Phoenix Instruments, Stealth Surgical, CareFusion, and Boss Instruments brand names.
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Phoenix I…1) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: McKenzie Perforator Drill, 13 mm; Phoenix Instruments Item Number: 157-6043; Lot Number: 070412. 2) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: Stealth Surgical; Stealth Surgical Product Name: McKenzie Perforator Drill, 13 mm; Stealth Surgical Item Number: SS2151; Lot Number: 070412. 3) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: CareFusion; CareFusion Product Name: McKenzie Perforator Drill, 13 mm; CareFusion Item Number: VM85-1235; Lot Number: 030211. 4) Instrumed Product Name: McKenzie Perforator Drill, 13 mm; Instrumed Product Number: 600-00591; Trade Name: CareFusion; CareFusion Product Name: McKenzie Perforator Drill, 13 mm; CareFusion Item Number: VM85-1251; Lot Number: 050111. |
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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-0545-2015%22
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