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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

Wright Medical Technology, Inc.: Infinity Resection Guide Adjustment Blocks Recalled for Missing Lock Screw

Agency Publication Date: April 4, 2024
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Summary

Wright Medical Technology is recalling 47 units of the Stryker Infinity Resection Adjustment Block used in ankle replacement surgeries. Three specific lots were found to be missing an internal screw that is essential for locking the side-to-side (medial/lateral) adjustment of the instrument. Consumers should contact their healthcare provider or the manufacturer to determine if their surgical equipment is affected.

Risk

The missing internal screw prevents the tool from locking into place properly. This could result in inaccurate bone cuts or misalignment during ankle arthroplasty surgery, potentially leading to surgical delays or the need for revision procedures.

What You Should Do

  1. Identify if you have the Stryker Infinity Resection Adjustment Block (REF 33600030) by checking the device packaging or hospital inventory records.
  2. Specifically look for affected Lot Numbers 2656950, 2762126, or 2796094 and UDI/DI 00889797004008.
  3. If you are a medical professional, immediately stop using the adjustment blocks from the affected lots and quarantine them to prevent use in surgery.
  4. Contact Wright Medical Technology / Stryker or your healthcare provider for further instructions regarding the return or replacement of these surgical instruments.
  5. For additional questions or to report an issue, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Device Quarantine

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

Affected Products

Product: Stryker Infinity Resection Adjustment Block (REF 33600030)
Model / REF:
33600030
UPC Codes:
00889797004008
Lot Numbers:
2656950
2762126
2796094

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94194
Status: Active
Manufacturer: Wright Medical Technology, Inc.
Sold By: Authorized medical distributors; Stryker sales representatives
Manufactured In: United States
Units Affected: 47 units
Distributed To: Texas, 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.