Anspach Effort Adult Craniotome Pneumatic System Recall for Missing Service Interval
The Anspach Effort, Inc. is recalling Adult Craniotome Pneumatic Systems because the supplied Directions for Use did not contain a recommended service interval.
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 specific hazard is a documentation error (missing service interval) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 2,878 units of Adult Craniotome Pneumatic Systems. The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected units are identified by Part No. Crani-A and DFU 18-0048. The recall includes all serial numbers shipped to customers prior to September 27, 2016. These products were distributed worldwide, including in the United States (specifically HI and DC), Puerto Rico, Guam, and Japan.
Consumers and healthcare facilities should stop using the affected craniotomes and contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.
The recalled product
- Product
- Adult Craniotome Product Usage: Pneumatic system
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 2,878
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 prior to 09/27/2016
- DFU 18-0048
- Part No. Crani-A.
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.
See all 103 products in this recall →Related recalls
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