Instrumed Recalls Cloward Spanner Gauges Due to Regulatory Non-Compliance
Instrumed International is withdrawing Cloward Spanner gauges because the company did not market them before 1976, failing to meet FDA requirements for pre-amendment devices.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is driven by regulatory documentation and marketing compliance issues (failure to meet pre-amendment requirements) rather than a physical defect or reported injury, fitting the criteria for Low severity.
Plain-English summary
Instrumed International, Inc. is voluntarily withdrawing Cloward Spanner gauges from the market. These are bone cutting and drilling instruments used without a power source on a patient's skull. The devices are sold under the CareFusion and Boss Instruments brand names.
The recall is being conducted because Instrumed did not market these specific devices prior to September 26, 1976. Consequently, the company does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. This is a regulatory compliance issue rather than a reported safety defect or malfunction.
The affected products include five specific Cloward Spanner gauges (Small and Large 5 1/8" sizes) with Lot Number 070412. These items were distributed nationwide, including in Arizona, California, Florida, Illinois, Kansas, Michigan, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and Virginia. Healthcare facilities and consumers should stop using these specific instruments and contact the manufacturer for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Instrumed International, Inc.
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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
- Boss Instruments Item Number: 74-1448
- Lot Number: 070412. 2) Instrumed Product Name: Cloward Spanner Gauge
- Trade Name: CareFusion
- CareFusion Product Name: Cloward Spanner Gauge
- CareFusion Item Number: VM85-2559
- Lot Number: 070412. 3) Instrumed Product Name: Cloward Spanner Gauge
- Large 5 1/8"
- Instrumed Product Number: 650-11869
- Boss Instruments Item Number: 74-1449
- Lot Number: 070412.
Distribution
Part of a larger recall action
This product is one of 28 recalled by Instrumed International, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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