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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

Zimmer Biomet Spine Inc.: Spinal Fixation System Screws Recalled for Incorrect Size Markings

Agency Publication Date: January 4, 2024
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Summary

Zimmer Biomet Spine Inc. is recalling 3 units of the Vitality Polyaxial Screw (7.5mm x 50mm) because the screws are laser-marked with the wrong size description. While the external packaging is correct, the screws themselves are incorrectly marked as '7.5 x 40'. This mismatch could lead a surgeon to use the wrong size screw during spinal surgery, potentially resulting in serious physical complications. This recall affects specific Vitality and Vital Spinal Fixation Systems distributed in Minnesota and Nebraska.

Risk

The use of a screw with an incorrect length could lead to screw perforation or indentation of vascular structures, nerves, or other critical tissues, which may cause internal injury or surgical complications.

What You Should Do

  1. Identify if you have the Vitality Polyaxial Screw (7.5mm x 50mm) by checking the external packaging for REF number 07.02000.118 and Lot number W834061.
  2. Check the physical screw for a laser-etched marking; affected screws will be incorrectly marked as '7.5 x 40' even though they are 50mm in length.
  3. Immediately stop using any screws from Lot W834061 and quarantine the product to prevent surgical use.
  4. Contact your healthcare provider if you have recently undergone spinal surgery involving the Vitality or Vital Spinal Fixation System and have concerns.
  5. Contact Zimmer Biomet Spine Inc. at their Westminster, Colorado headquarters or through your local sales representative for instructions on returning the affected screws.
  6. For further information or questions regarding this recall, contact the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer contact

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

Affected Products

Product: Vitality Polyaxial Screw, 7.5mm x 50mm
Model / REF:
REF: 07.02000.118
Vitality Spinal Fixation System
Vital Spinal Fixation System
Lot Numbers:
W834061

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93650
Status: Active
Manufacturer: Zimmer Biomet Spine Inc.
Sold By: Hospitals; Surgical Centers
Manufactured In: United States
Units Affected: 3
Distributed To: Minnesota, Nebraska

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.