Anspach Effort Recalls Large Craniotomes Due to Missing Service Interval Instructions
The Anspach Effort, Inc. is recalling 31 Large Craniotome, Black Max units because the supplied directions for use did not include a recommended service interval.
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 and involves a documentation issue (missing service interval) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 31 units of the Large Craniotome, Black Max. The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected products were distributed worldwide, including in the United States (specifically Hawaii and the District of Columbia), Puerto Rico, Guam, and Japan. The recall involves all serial numbers shipped to customers, identified by DFU 18-0062 and Part No. B-GOLD.
The U.S. Food and Drug Administration has classified this as a Class II recall. Users of these devices should contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.
The recalled product
- Product
- LARGE CRANIOTOME, BLACK MAX
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 31
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 (3)
- All serial numbers shipped to customers
- DFU 18-0062
- Part No. B-GOLD.
Distribution
Part of a larger recall action
This product is one of 103 recalled by The Anspach Effort, 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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