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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/Surgical Equipment

Medagent Inc: Rebstock Holding Rods Recalled Due to Uncontrollable Movement Risk

Agency Publication Date: February 23, 2024
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Summary

Medagent Inc is recalling 84 units of Rebstock Holding rods used for fixation of surgical instruments like Leyla Arms and spatulas. These rods are used in surgical environments to stabilize instruments, but the holding arm can move or twist uncontrollably during use. If this movement is transferred to an attached spatula, it could cause serious injury to a patient. You should contact your healthcare provider or Medagent Inc for further instructions regarding these affected surgical tools.

Risk

The holding arm can unexpectedly twist or shift, potentially moving surgical instruments during a procedure and causing unintended trauma or injury to the patient.

What You Should Do

  1. Identify if you have the Rebstock Holding rod for fixation (surgical instrument) with Article Numbers 06-06-285 or 06-06-285MOD.
  2. Check the device for the following affected batch numbers: 6221672, 6222079, 6230282, 6230985, 6230986, 6231808, 6222559, 6231989, or 6221673.
  3. Immediately stop using any holding rods from the affected batches and isolate them from active surgical inventory.
  4. Contact Medagent Inc or your healthcare facility's equipment manager to coordinate the return or repair of the defective units.
  5. Contact your healthcare provider or Medagent Inc for further instructions and potential refund.
  6. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Rebstock Holding rod for fixation
Model / REF:
06-06-285
06-06-285MOD
Lot Numbers:
6221672
6222079
6230282
6230985
6230986
6231808
6222559
6231989
6221673

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93840
Status: Active
Manufacturer: Medagent Inc
Sold By: Specialty medical distributors
Manufactured In: United States
Units Affected: 84 units
Distributed To: Texas

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.