Home / Recalls / Instrumed International, Inc. / Z-0555-2015

Z-0555-2015 Class II Terminated

Recalled by Instrumed International, Inc. — Schaumburg, IL

Recall Details

Product Type
Devices
Report Date
December 17, 2014
Initiation Date
September 8, 2014
Termination Date
November 29, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 Gardner-Wells wrenches

Product Description

Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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: Gardner-Wells Titanium Wrench 1/2"; Instrumed Product Number: 638-05441; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Wrench 1/2"; CareFusion Item Number: VM85-12015; Lot Number: 011112. 2) Instrumed Product Name: Gardner-Wells Titanium Wrench 1/2"; Instrumed Product Number: 638-05441; Trade Name: CareFusion; CareFusion Product Name: Gardner-Wells Titanium Wrench 1/2"; CareFusion Item Number: NL9516-T; Lot Number: 011112.

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