FDA Device recall Z-0549-2015
Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareF…
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareF… by Instrumed International, citing the reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet….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-0549-2015 |
| 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
Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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: Galt Trephine, 5/8"; Instrumed Product Number: 600-01091; Trade Name: CareFusion; CareFusion…1) Instrumed Product Name: Galt Trephine, 5/8"; Instrumed Product Number: 600-01091; Trade Name: CareFusion; CareFusion Product Name: Galt Trephine, 5/8"; CareFusion Item Number: VM85-1273; Lot Number: 120411. |
|---|
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-0549-2015%22
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