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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
Medical Devices/Implants & Prosthetics

Stryker CinchLock Flex Knotless Anchors Recalled for Pullwire Breakage Risk

Agency Publication Date: March 12, 2025
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Summary

Stryker Corporation is recalling 9,521 units of the CinchLock Flex Knotless Anchor with Inserter and Suture (model REF CAT02643). The recall follows an increase in reports that the surgical device's "pullwire" can break during use. If the pullwire breaks, a piece of it may remain inside the anchor implant body after it is deployed in a patient's body. While the company has noted an increase in complaints, specific injury counts have not been provided.

Risk

A broken pullwire remaining inside an implant can cause patient injury, inflammation, or complications requiring additional medical intervention to address the retained fragment.

What You Should Do

  1. This recall affects the Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, specifically catalog number (REF) CAT02643 with Unique Device Identifier (UDI) 07613327123661.
  2. Hospital staff and surgeons should check their inventory for affected lot numbers. More than 60 specific lots are included in this recall; see the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately. Contact Stryker Corporation or your medical supply distributor to arrange for the return, replacement, or correction of any unused inventory.
  4. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this safety notice.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Stryker CinchLock Flex Knotless Anchor with Inserter and Suture
Variants: Sterile EO, Rx Only, MR Safe
Model / REF:
CAT02643
Lot Numbers (64):
23342AE2
24190AE2
23345AE2
24200AE2
24004AE2
24201AE2
24008AE2
24204AE2
24009AE2
24205AE2
24010AE2
24206AE2
24032AE2
24214AE2
24033AE2
24215AE2
24036AE2
24221AE2
24050AE2
24222AE2
24061AE2
24226AE2
24064AE2
24233AE2
24065AE2
24235AE2
24066AE2
24240AE2
24087AE2
24248AE2
24093AE2
24249AE2
24094AE2
24250AE2
24127AE2
24256AE2
24128AE2
24257AE2
24135AE2
24258AE2
24136AE2
24260AE2
24137AE2
24276AE2
24143AE2
24277AE2
24144AE2
24278AE2
24159AE2
24283AE2
UDI:
07613327123661

Recall #: Z-1328-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96281
Status: Active
Manufacturer: Stryker Corporation
Sold By: Hospitals; Surgical Centers; Medical Supply Distributors
Manufactured In: United States
Units Affected: 9521 units
Distributed To: Nationwide

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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 ยท 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.