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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

Stryker Corporation: Stryker iBur Medical Devices Recalled for Potential Thermal Injury Risk

Agency Publication Date: August 26, 2024
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Summary

Stryker Corporation is recalling approximately 23,330 iBur surgical burrs across several models, including Precision Round, Diamond Round, and Match Head versions. These devices, used in neuro, spine, and ENT surgeries, may reach temperatures higher than safety specifications where the burr meets its distal bushing. If this overheating occurs during a procedure, it can lead to thermal injury or minor tissue damage that may require additional medical or surgical intervention. Consumers and healthcare facilities should identify affected lots and contact the manufacturer for further instructions.

Risk

The burr shank can overheat at the distal bushing interface, creating a risk of thermal burns to delicate tissues and structures during surgical procedures. While the risk level is moderate, such injuries could necessitate secondary medical or surgical procedures to repair the damaged tissue.

What You Should Do

  1. Check your surgical inventory for Stryker iBur models with the following reference numbers: 8431-009-030, 8431-009-040, 8431-012-020D, 8431-012-030D, 8431-012-040D, 8431-013-030DC, 8431-013-040DC, 8431-013-050DC, 8431-107-030D, and 8431-107-530.
  2. Verify the lot numbers on your products against the affected list, which includes lots such as 22224017, 23157017, 24004027, and 23345027 among many others across the product line.
  3. If you identify an affected product, immediately quarantine it and stop use to prevent potential thermal injury to patients.
  4. Contact Stryker Corporation directly at their Portage, Michigan headquarters or through your local sales representative to discuss the voluntary recall and receive specific instructions on returning or replacing the affected units.
  5. Contact your healthcare provider if you have concerns regarding a previous surgery where these specific burrs may have been used.
  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

Manufacturer correction/replacement

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

Affected Products

Product: Stryker iBur 3.0mm Precision Round, Distal Bend
Model / REF:
Ref: 8431-009-030
Recall #: Z-2722-2024
UPC Codes:
07613327501247
Lot Numbers:
22224017
22234017
22234027
22250017
22293017
22299017
23157017
23179017
23179027
23299017
Product: Stryker iBur 4.0mm Precision Round, Distal Bend
Model / REF:
Ref: 8431-009-040
Recall #: Z-2723-2024
UPC Codes:
07613327501223
Lot Numbers:
22245017
22248017
22270017
22299017
22306027
23188017
Product: Stryker iBur 2.0mm Diamond Round, Distal Bend
Model / REF:
Ref: 8431-012-020D
Recall #: Z-2724-2024
UPC Codes:
07613327501261
Lot Numbers:
22237017
22241017
22334017
23085017
23179017
23213017
24003017
24015017
Product: Stryker iBur 3.0mm Diamond Round, Distal Bend
Model / REF:
Ref: 8431-012-030D
Recall #: Z-2725-2024
UPC Codes:
07613327501230
Lot Numbers:
22216017
22230017
22334017
23004017
23004027
23009017
23157017
23208017
23233017
23233027
24003017
Product: Stryker iBur 4.0mm Diamond Round, Distal Bend
Model / REF:
Ref: 8431-012-040D
Recall #: Z-2726-2024
UPC Codes:
07613327501278
Lot Numbers:
22334017
22339017
23004017
23016017
23085017
23115017
23195017
23299017
Product: Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend
Model / REF:
Ref: 8431-013-030DC
Recall #: Z-2727-2024
UPC Codes:
07613327501209
Lot Numbers:
22230017
22333017
22342017
23011017
23093017
23172017
23188017
23221017
23311017
24004027
Product: Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend
Model / REF:
Ref: 8431-013-040DC
Recall #: Z-2728-2024
UPC Codes:
07613327501155
Lot Numbers:
22248017
22263017
22334017
22348017
22348027
23016027
23095027
23128017
23163017
23179017
23205017
23205027
23205037
23221017
23311017
24004017
24004027
24004037
Product: Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend
Model / REF:
Ref: 8431-013-050DC
Recall #: Z-2729-2024
UPC Codes:
07613327501186
Lot Numbers:
22224017
22227017
23087017
23157017
23188017
23342017
Product: Stryker iBur 3.0mm Diamond Match Head, Distal Bend
Model / REF:
Ref: 8431-107-030D
Recall #: Z-2730-2024
UPC Codes:
07613327509229
Lot Numbers:
22334017
23047017
23095017
23198017
Product: Stryker iBur 3.0mm Precision Match Head, Distal Bend
Model / REF:
Ref: 8431-107-530
Recall #: Z-2731-2024
UPC Codes:
07613327501193
Lot Numbers:
22228017
22257017
22269017
22276017
23085017
23095017
23157017
23157027
23179017
23179027
23198017
23213017
23221017
23299017
23345017
23345027

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95040
Status: Resolved
Manufacturer: Stryker Corporation
Sold By: Stryker Corporation authorized distributors; Direct medical sales channels
Manufactured In: United States
Units Affected: 10 products (1612 units; 1227 units; 1226 units; 2507 units; 1706 units; 2670 units; 5031 units; 1171 units; 2507 units; 3673 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.