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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

Synthes (USA) Products LLC: Stardrive Screwdrivers Recalled Due to Tip Defect and Surgical Delay Risk

Agency Publication Date: May 28, 2024
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Summary

Synthes (USA) Products LLC is recalling 261 Stardrive Screwdriver Shafts (T4 50mm) used during orthopaedic surgeries to tighten or remove screw implants. The screwdriver tips were manufactured without a necessary 5-degree relief cut, which prevents them from properly engaging with 1.3mm and 1.5mm screws. This defect can lead to interruptions during medical procedures and potential surgical delays. These products were distributed nationwide in the United States and Canada.

Risk

The screwdriver tip will not fit into or grip the intended screws, which can cause the tool to fail during a live operation, potentially leading to increased anesthesia time or surgical complications due to delays.

What You Should Do

  1. Identify your device by checking the packaging or the tool for Part Number 03.130.010 and UDI-DI 10886982075192.
  2. Verify if your screwdriver belongs to one of the affected lots: 97P6250, 97P6251, or 97P6252.
  3. If you have an affected screwdriver, immediately stop using it and set it aside to ensure it is not used in surgical procedures.
  4. Contact Synthes (USA) Products LLC or your healthcare facility's equipment manager to arrange for a return or to receive further instructions on obtaining a replacement.
  5. Healthcare providers with questions can contact the manufacturer directly for assistance with the recall process.
  6. For additional information, 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: STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC
Model / REF:
03.130.010
UDI-DI: 10886982075192
Lot Numbers:
97P6250
97P6251
97P6252

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94546
Status: Active
Manufacturer: Synthes (USA) Products LLC
Sold By: Authorized distributors; Medical facilities
Manufactured In: United States
Units Affected: 261 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.