Anspach 2.37mm Spiral Drill Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling 10 units of the 2.37mm Spiral Drill because they were not manufactured consistently with Quality System requirements.
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 does not report any injuries, illnesses, or specific functional defects, fitting the criteria for a voluntary precautionary recall or minor quality issue.
Plain-English summary
The Anspach Effort, Inc. is recalling 10 units of the Anspach 2.37mm Spiral Drill, Part Number 98-0010, Serial Number 200341. The device is a non-sterile, prescription-only medical instrument intended for use with Anspach Systems.
The recall was initiated because the units were not manufactured consistently with Quality System requirements. The source text does not specify the exact nature of the manufacturing inconsistencies or report any specific patient injuries or illnesses.
The affected units were distributed worldwide, including to specific US states (AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX) and internationally to Canada, Japan, Hungary, Korea, and Sweden. Healthcare providers and patients should contact The Anspach Effort, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 10
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 (2)
- Part Number: 98-0010
- Serial Number: 200341
Distribution
Part of a larger recall action
This product is one of 45 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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