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Recall Observatory FDA recall evidence

Device 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.

Z-0549-2015

September 08, 2014

Class II

Product summary

Firm
Instrumed International, Inc.
Event
Event 69471
Status
Terminated
Classification
Class II
Quantity
3 Galt trephines
Official record key
device-enforcement:Z-0549-2015

Official wording

Reason: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.

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.

Distribution pattern: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.