Anspach Custom Devices Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Devices 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 cites a manufacturing quality system issue without reporting specific injuries, illnesses, or structural defects, aligning with a moderate severity for a voluntary precautionary or quality-based recall.
Plain-English summary
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The recall is due to the units not being manufactured consistently with Quality System requirements.
The affected product is the ANSPACH REF SP-4601-00 1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment. This device is intended to be used with Anspach Systems and is available by prescription only. The specific units involved have Part Number SP-4601-00 and Serial Number 200093.
The recall involves 10 units. Distribution was worldwide, including the United States (AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX) and internationally to Canada, Japan, Hungary, Korea, and Sweden. No specific instructions for consumers are provided in the source text.
The recalled product
- Product
- ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Category
- Medical Device — Custom Devices
- 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: SP-4601-00
- Serial Number: 200093
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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