Anspach Arthroscopic Suture Anchor Threaders Recalled for Quality System Non-Compliance
The Anspach Effort, Inc. is recalling Anspach Custom Devices, specifically arthroscopic suture anchor threaders, 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 the source text does not report any illnesses, injuries, or hospitalizations. The hazard is related to manufacturing quality system non-compliance rather than a specific acute safety defect like fire or choking, fitting the Moderate criteria for low-risk or precautionary recalls.
Plain-English summary
The Anspach Effort, Inc. is recalling its Anspach Custom Devices, specifically the Anspach Threaders, Arthroscopic Suture Anchor (Part Number SP-5000-00). The recall involves 30 units with serial numbers 200174, 200173, and 200161.
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, TX) and internationally to Canada, Japan, Hungary, Korea, and Sweden. Healthcare providers and patients should contact the manufacturer or their supplier for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 30
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 (4)
- Part Number: SP-5000-00
- Serial Numbers: 200174
- 200173
- 200161.
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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