Z-0549-2015 Class II Terminated
FDA device recall Z-0549-2015 was initiated by Instrumed International, Inc. on Sep 8, 2014 and is designated Class II. Reason for recall: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements… The recall status is terminated (terminated Nov 29, 2017). Affected quantity: 3 Galt trephines.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 17, 2014
- Initiation Date
- Sep 8, 2014
- Termination Date
- Nov 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 Galt trephines
Product Description
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 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
Distribution Pattern
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0549-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026