Anspach Sagittal microSaw Attachment Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling two custom Sagittal microSaw Attachments 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 illnesses, injuries, or hospitalizations, and the defect is a manufacturing consistency issue rather than a direct physical hazard like fire or shock.
Plain-English summary
The Anspach Effort, Inc. in Palm Beach Gardens, Florida, is recalling two units of the Anspach Sagittal microSaw Attachment Custom (Part Number 98-0003). The specific units affected have serial numbers 20030101 and 20030102.
The recall was initiated because the units were not manufactured consistently with Quality System requirements. The FDA has classified this recall as Class II.
The affected devices were distributed worldwide, including in the United States (AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, and TX) and internationally to Canada, Japan, Hungary, Korea, and Sweden. The Anspach Effort, Inc. is the recalling firm.
The recalled product
- Product
- ANSPACH***REF 98-0003***Sagittal microSaw Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 2
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)
- Part Number 98-0003
- Serial Numbers: 20030101
- 20030102.
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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