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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Arthrex, Inc.: Some eyelets broke from SwiveLock Anchor on insertion.

Agency Publication Date: May 5, 2017
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Affected Products

Product: Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

Unique Device Identifier: 00888867026766 Batch Number: 1078259 Expiration Date 11/30/2018

Lot Numbers:
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Product: Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching

Unique Device Identifier: 00888867026803 Batch Number: 10078258 Expiration Date 12/01/2021

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Number
Product: Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching

Unique Device Identifier: 00888867026865 Batch Number: 10072425 - Expiration Date 10/31/2018 Batch Number: 10073992 - Expiration Date 10/31/2018 Batch Number: 10077133 - Expiration Date 10/31/2018 Batch Number: 10078077 - Expiration Date 11/30/2018 Batch Number: 10078340 - Expiration Date 11/30/2018 Batch Number: 10075792 - Expiration Date 10/31/2018

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Product: Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching

Unique Device Identifier: 00888867026926 Batch Number: 10072597 - Expiration Date 10/31/2021

Lot Numbers:
Number
Product: Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm

Unique Device Identifier: 00888867027329 Batch Number: 10072597 - Expiration Date 10/31/2018 Batch Number: 10074288 - Expiration Date 10/31/2018 Batch Number: 10076753 - Expiration Date 10/31/2018 Batch Number: 10076852 - Expiration Date 10/31/2018 Batch Number: 10081420 - Expiration Date 11/30/2018 Batch Number: 10075965 - Expiration Date 10/31/2018 Batch Number: 10077252 - Expiration Date 10/31/2018 Batch Number: 10084027 - Expiration Date 12/31/2017

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Product: Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching

Unique Device Identifier: 00888867160231 Batch Number: 10070003 - Expiration Date 9/30/2021

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 76986
Status: Resolved
Manufacturer: Arthrex, Inc.
Manufactured In: United States

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.