Anspach Effort Recalls Pediatric Craniotomes Due to Missing Service Interval
The Anspach Effort, Inc. is recalling 679 Pediatric Craniotomes 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 defect is a documentation issue (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 679 units of the Pediatric Craniotome (Part No. CRANI-P). The recall is being conducted because the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected units were distributed worldwide, including in the United States (specifically HI, DC, and PR) and in the countries of Guam and Japan. The recall covers all serial numbers shipped to customers prior to September 27, 2016, under DFU 18-0048.
Healthcare facilities and users should stop using the affected devices and contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.
The recalled product
- Product
- Pediatric Craniotome
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 679
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-P.
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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