Anspach Effort Recalls Rotating Large Craniotomes Due to Missing Service Interval
The Anspach Effort, Inc. is recalling eight Rotating Large 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 specific defect is a documentation error (missing service interval) with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling/documentation issue.
Plain-English summary
The Anspach Effort, Inc. is recalling eight units of the Rotating Large Craniotome (Part No. CRANI-L-R). The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected units are identified by DFU 18-0048 and include all serial numbers shipped to customers prior to September 27, 2016. The products were distributed worldwide, including nationwide in the United States (specifically Hawaii and the District of Columbia), Puerto Rico, Guam, and Japan.
Consumers and healthcare facilities 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
- Rotating Large Craniotome
- 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 (3)
- All serial numbers shipped to customers prior to 09/27/2016
- DFU 18-0048
- Part No. CRANI-L-R.
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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