Instrumed International, Inc. 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. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Instrumed International, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Instrumed International, Inc. is recalling Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power sourc due to 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, . This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026