Anspach G1 High Speed Electric Handpiece Recalled for Reversed Interface Graphics
The Anspach Effort, Inc. is recalling 18 Anspach G1 High Speed Electric Handpiece Air Cooled units because the graphics indicating locked and unlocked positions are reversed.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error (reversed graphics) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 18 units of the Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A). This medical device is used for cutting and shaping bone, including bones of the cranium and spine.
The recall was initiated because the graphics at the attachment interface indicating locked and unlocked positions are reversed. This labeling error could potentially lead to incorrect usage of the device.
The affected units were distributed worldwide, including in the United States (Georgia and Florida) and Switzerland. The specific lot numbers involved are H29309439804, H44310033104, K09311396703, and K09311396704. Users should stop using the device and contact the manufacturer for instructions.
The recalled product
- Product
- Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 18
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 (4)
- Lot #'s: H29309439804
- H44310033104
- K09311396703
- and K09311396704.
Distribution
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