Anspach Knotless Suture Anchor Deployment Tool Recalled for Quality Issues
The Anspach Effort, Inc. is recalling Knotless Suture Anchor Deployment Tools because the units and records were not consistent 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 explicitly states the issue is a lack of consistency with Quality System requirements without reporting any injuries, illnesses, or specific functional defects that pose an immediate physical hazard. This aligns with the rubric for moderate severity involving documentation or quality system issues where harm is not reported.
Plain-English summary
The Anspach Effort, Inc. is recalling the Anspach Knotless Suture Anchor Deployment Tool. This device is intended to be used with Anspach Systems and is available by prescription only.
The recall was initiated because the units and the records of these products were not consistent with Quality System requirements. The source text does not report any specific injuries, illnesses, or deaths associated with the use of these devices.
The affected products include Part Numbers 98-0006 and 98-0009, with Serial Numbers 20030001, 20030002, 20033501, and 20033502. A total of 4 units were distributed worldwide, including to the United States and internationally to Canada, Japan, Hungary, Korea, and Sweden. Healthcare providers and facilities should check their inventory for these specific serial and part numbers and stop using the devices if they match the recalled units.
The recalled product
- Product
- ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 4
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 Numbers: 98-0006
- 98-0009. Serial Numbers: 20030001
- 20030002 20033501
- 20033502.
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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