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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

In2Bones, SAS: I.B.S. Compression Screws Recalled for Batch Mix-Up and Incorrect Lengths

Agency Publication Date: March 20, 2024
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Summary

In2Bones, SAS is recalling 122 units of I.B.S. Compression Screws because of a batch mix-up where 75mm screws and 80mm screws were swapped. As a result, the screws in these batches may have different physical lengths than what is printed on their sterile labels. This recall affects the 6.5-C Compression Screw model distributed in Tennessee.

Risk

If a surgeon uses a screw that is longer or shorter than the size indicated on the label, it could lead to incorrect placement during surgery. This may cause improper bone fixation, potential nerve or tissue damage from an over-long screw, or surgical delays while a correct replacement is located.

What You Should Do

  1. Check your surgical inventory for I.B.S. 6.5-C Compression screws with Part Number S65 ST175 (75mm) and Part Number S65 ST180 (80mm).
  2. Specifically look for Batch Number 2306007 (UDI/DI 3760225710685) and Batch Number 2306008 (UDI/DI 3760225710692), both with an expiration date of 31/MAY/2028.
  3. Identify any affected units and immediately quarantine them to ensure they are not used in surgical procedures.
  4. Contact your healthcare provider or In2Bones, SAS at their headquarters in Ecully, France, for further instructions regarding the return or replacement of these medical devices.
  5. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional questions.

Your Remedy Options

📋Other Action

healthcare provider or manufacturer notification

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

Affected Products

Product: I.B.S. 6.5-C Compression screw - diam 6.5mm lg 75mm
Model / REF:
Part Number S65 ST175
UDI/DI 3760225710685
Lot Numbers:
Batch Number 2306007 (Exp. 31/MAY/2028)
Product: I.B.S. 6.5-C Compression screw - diam 6.5mm lg 80mm
Model / REF:
Part Number S65 ST180
UDI/DI 3760225710692
Lot Numbers:
Batch Number 2306008 (Exp. 31/MAY/2028)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94063
Status: Active
Manufacturer: In2Bones, SAS
Sold By: Authorized distributors in Tennessee
Manufactured In: France
Units Affected: 2 products (59 units; 63 units)
Distributed To: Tennessee

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 · 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.