Anspach Effort Recalls Standard Craniotomes Due to Missing Service Interval
The Anspach Effort, Inc. is recalling 148 Standard Craniotomes 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, but the source text describes a documentation issue (missing service interval) without reporting any injuries, illnesses, or specific physical hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 148 units of the Standard Craniotome, Black Max. The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected devices were distributed worldwide, including nationwide in the United States (specifically Hawaii and the District of Columbia), Puerto Rico, Guam, and Japan. The specific units are identified by DFU 18-0062 and Part No. B-GREEN.
The FDA has classified this as a Class II recall. Users should contact the manufacturer for further instructions regarding the missing service interval information.
The recalled product
- Product
- STANDARD CRANIOTOME, BLACK MAX
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 148
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-GREEN.
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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