Anspach Modified Arthroscopic Knotless Suture Anchor Deployment Tool Recalled
The Anspach Effort, Inc. is recalling Modified Arthroscopic Knotless Suture Anchor Deployment Tools 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 manufacturing inconsistency with Quality System requirements but does not report any specific injuries, illnesses, or deaths, aligning with a moderate severity rating for a voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling its Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller. The recall is being conducted because the units were not manufactured consistently with Quality System requirements.
The recalled device is intended to be used with Anspach Systems. The specific unit identified in the recall has Part Number 98-0020 and Serial Number 200423. The distribution pattern indicates worldwide distribution, including the United States and international locations such as Canada, Japan, Hungary, Korea, and Sweden.
Consumers and healthcare providers should stop using the recalled device and contact The Anspach Effort, Inc. for further instructions.
The recalled product
- Product
- ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx Only*** This device is intended to be used with Anspach Systems
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 1
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 98-0020
- Serial Number: 200423
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.
See all 45 products in this recall →Related recalls
Same manufacturer · The Anspach Effort, Inc.
See all →- HighAdult Craniotome Bearings May Detach During Surgical Use
FDA (Devices) · 2023-01-18
- HighCraniotome Attachment Ball Bearings May Separate During Surgery
FDA (Devices) · 2023-01-18
- HighLarge Craniotome Attachment Ball Bearings Risk Loosening During Surgery
FDA (Devices) · 2023-01-18
- HighAnspach Adult Rotating Craniotome Attachment ball bearings may detach during surgery
FDA (Devices) · 2023-01-18
- HighCraniotome Attachment Ball Bearings May Detach During Surgery
FDA (Devices) · 2023-01-18
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighAnspach Effort Pneumatic Drill System Recalled Due to Hose Rupture Risk
FDA (Devices) · 2014-01-15
- SevereAnspach Pneumatic Drill System Recalled Due to Hose Rupture Risk
FDA (Devices) · 2014-01-15
- ModerateAnspach Effort 16cm Minimally Invasive Attachment Pneumatic System Recall
FDA (Devices) · 2017-05-10
- ModerateAnspach Effort Minimal Access Attachment Pneumatic System Recall
FDA (Devices) · 2017-05-10
- ModerateAnspach Effort Recalls 10.5cm QD Angle Attachment for Pneumatic Systems
FDA (Devices) · 2017-05-10
- ModerateAnspach Effort Pneumatic System Attachment Recalled for Missing Service Interval
FDA (Devices) · 2017-05-10