Anspach recalls 20 diamond ball attachments for quality system non-compliance
The Anspach Effort, Inc. is recalling 20 units of 2mm Coarse Diamond Ball 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 and involves a manufacturing quality system non-compliance without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 20 units of the 2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment (Part Number SP-4602-00). The affected units have serial numbers 200278 and 200094. These devices are intended to be used with Anspach Systems and are prescription-only.
The recall was initiated because the units were not manufactured consistently with Quality System requirements. The FDA has classified this as a Class II recall.
The affected products were distributed worldwide, including in 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. Consumers and healthcare providers should stop using the affected devices and contact The Anspach Effort, Inc. for further instructions.
The recalled product
- Product
- ANSPACH***REF SP-4602-00***2mm 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.
- Affected units
- 20
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: SP-4602-00
- Serial Numbers: 200278
- 200094
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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