Tornier, Inc: Perform Humeral Nucleus Recalled for Potential Bacterial Endotoxin Contamination

Agency Publication Date: September 16, 2024

Summary

Tornier, Inc. has recalled five units of the Stryker Tornier Perform Humeral System - Stemless US Anatomic Nucleus, which is a medical device used in shoulder replacement surgery. One specific lot of these humeral implants may exceed the safe specification for bacterial endotoxin load. This recall involves the Anatomic Nucleus model with reference number DWM003A, which was distributed to healthcare facilities in five states: Illinois, Wisconsin, Arizona, Nevada, and South Dakota.

Risk

The presence of bacterial endotoxins above the safe limit (20 EU/device) can cause an inflammatory response, fever, or other serious systemic reactions in patients receiving the shoulder implant. While only five units are affected, the contamination poses a moderate risk of adverse biological reactions following surgery.

What You Should Do

Identify if you have the affected shoulder implant by checking for the Stryker Tornier Perform Humeral System - Stemless US Anatomic Nucleus (REF DWM003A) with Lot number 3268BA and UDI/DI 00846832092192.
Healthcare providers and facilities should immediately stop using units from Lot number 3268BA and quarantine any remaining inventory.
If you have already undergone a shoulder replacement surgery involving this device, contact your surgeon or healthcare provider to discuss the potential risks and any necessary follow-up monitoring.
Contact Tornier, Inc. at their Bloomington, Minnesota office or through the manufacturer's representative to arrange for the return of the affected product.
For additional information or questions, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer and Healthcare Consultation

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

Affected Products

Product: stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus

Model / REF:

REF DWM003A

UPC Codes:

00846832092192

Lot Numbers:

3268BA

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95258

Status: Active

Manufacturer: Tornier, Inc

Sold By: hospitals; surgical centers

Manufactured In: United States

Units Affected: 5 units

Distributed To: Illinois, Wisconsin, Arizona, Nevada, South Dakota

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.

Summary

Risk

What You Should Do

Identify if you have the affected shoulder implant by checking for the Stryker Tornier Perform Humeral System - Stemless US Anatomic Nucleus (REF DWM003A) with Lot number 3268BA and UDI/DI 00846832092192.

Healthcare providers and facilities should immediately stop using units from Lot number 3268BA and quarantine any remaining inventory.

If you have already undergone a shoulder replacement surgery involving this device, contact your surgeon or healthcare provider to discuss the potential risks and any necessary follow-up monitoring.

Contact Tornier, Inc. at their Bloomington, Minnesota office or through the manufacturer's representative to arrange for the return of the affected product.

For additional information or questions, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.