FDAFDA · Food and drugs·Recall number Z-0557-2015
Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments brand names.
Published December 17, 2014 · Recall initiated: September 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Instrumed International, Inc.
- Distributor
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Lot
- 1) Instrumed Product Name: Cloward Spanner Gauge, Small 5 1/8"; Instrumed Product Number: 650-11864; Trade Name: Boss Instruments; Boss Instruments Product Name: Cloward Spanner Gauge, Small 5 1/8"; Boss Instruments Item Number: 74-1448; Lot Number: 070412. 2) Instrumed Product Name: Cloward Spanner Gauge, Small 5 1/8"; Instrumed Product Number: 650-11864; Trade Name: CareFusion; CareFusion Product Name: Cloward Spanner Gauge, Small 5 1/8"; CareFusion Item Number: VM85-2559; Lot Number: 070412. 3) Instrumed Product Name: Cloward Spanner Gauge, Large 5 1/8"; Instrumed Product Number: 650-11869; Trade Name: Boss Instruments; Boss Instruments Product Name: Cloward Spanner Gauge, Large 5 1/8"; Boss Instruments Item Number: 74-1449; Lot Number: 070412.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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