FDA Recalls 16cm Minimally Invasive Attachment Due to Incorrect Color Bands
The Anspach Effort, Inc. is recalling 8 units of the MIA16-G1 Minimally Invasive Attachment because customer complaints indicated the color bands were not correct.
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, but the source text describes a labeling defect (incorrect color bands) without reporting any injuries, illnesses, or serious adverse health consequences, fitting the criteria for a moderate severity recall involving minor labeling errors.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 8 units of the 16cm Minimally Invasive Attachment, Model MIA16-G1, manufactured by The Anspach Effort, Inc. This medical device is used with motor systems for cutting and shaping bones, including the spine and cranium.
The recall was initiated following a customer complaint indicating that the color bands on the MIA16-G1 were not correct. The affected units are identified by the following serial numbers: H38309606702, H38309606704, H38309610105, H38309610104, H38309606701, H38309606703, H38309606705, and H38309610101.
The affected products were distributed in the United States to North Carolina and California, and internationally to Switzerland. Healthcare providers and consumers should check their inventory for these specific serial numbers and contact The Anspach Effort, Inc. for instructions on how to return or replace the devices.
The recalled product
- Product
- 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 8
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 (8)
- Serial Numbers: H38309606702
- H38309606704
- H38309610105
- H38309610104
- H38309606701
- H38309606703
- H38309606705
- H38309610101.
Distribution
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