FDA Device recall Z-0544-2015
Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetr…
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetr… by Instrumed International, citing the reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet….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-0544-2015 |
| 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
Hudson burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, CareFusion, Boss Instruments, and Medline Industries 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Symmetry Surgical; Symme…1) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Hudson Burr, 9 mm; Symmetry Surgical Item Number: 57-6009; Lot Number: 030211. 2) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Medfix International; Medfix International Product Name: Hudson Burr, 9 mm; Medfix International Item Number: MF223-1612; Lot Number: 060410. 3) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: CareFusion; CareFusion Product Name: Hudson Burr, 9 mm; CareFusion Item Number: VM85-1235; Lot Number: 030211. 4) Instrumed Product Name: Hudson Burr, 9 mm; Instrumed Product Number: 600-00549; Trade Name: Boss Instruments; Boss Instruments Product Name: Hudson Burr, 9 mm; Boss Instruments Item Number: 74-0124; Lot Number: 060410. 5) Instrumed Product Name: Hudson Burr, 10 mm; Instrumed Product Number: 600-00553; Trade Name |
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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-0544-2015%22
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