Anspach recalls 3mm Coarse Diamond Ball attachments for quality system issues
The Anspach Effort, Inc. is recalling 40 units of 3mm Coarse Diamond Ball attachments because they were not manufactured consistently with Quality System requirements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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. The source text cites a failure to meet Quality System requirements without reporting specific injuries, illnesses, or deaths, which aligns with the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
The Anspach Effort, Inc. is recalling 40 units of the 3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment (Part Number SP-4603-00). The recall affects specific serial numbers: 200280, 200281, 200279, and 200095. These devices are intended for use with Anspach Systems and are prescription-only.
The recall was initiated because the units were not manufactured consistently with Quality System requirements. 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 instructions on how to return or replace the units.
The recalled product
- Product
- ANSPACH***REF SP-4603-00***3mm 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.
- Hazard
- Affected units
- 40
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 (5)
- Part Number: SP-4603-00
- Serial Numbers: 200280
- 200281
- 200279
- 200095.
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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