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.
What this means for you
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
Related recalls
Same manufacturer · The Anspach Effort, Inc.
See all →- HighAdult Craniotome Bearings May Detach During Surgical Use
FDA (Devices) · 2023-01-18
- HighCraniotome Attachment Ball Bearings May Separate During Surgery
FDA (Devices) · 2023-01-18
- HighLarge Craniotome Attachment Ball Bearings Risk Loosening During Surgery
FDA (Devices) · 2023-01-18
- HighAnspach Adult Rotating Craniotome Attachment ball bearings may detach during surgery
FDA (Devices) · 2023-01-18
- HighCraniotome Attachment Ball Bearings May Detach During Surgery
FDA (Devices) · 2023-01-18
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02