Howmedica Osteonics Corp.: UNITRAX Endoprosthesis Head Components Recalled for Mislabeled Sizes

Agency Publication Date: July 16, 2024

Summary

Howmedica Osteonics (Stryker) is recalling 48 units of UNITRAX Endoprosthesis Head Components because the size listed on the outer package label may not match the actual device inside. This recall affects the 43mm, 42mm, and 38mm sizes used in partial hip replacement surgeries. If an incorrectly sized implant is used during surgery, it could lead to improper joint fit or surgical delays. Consumers should contact their healthcare provider or the manufacturer for further instructions and information regarding potential refunds.

Risk

The size discrepancy between the label and the physical device could result in a surgeon attempting to implant the wrong size component, potentially causing surgical delays while a replacement is found or improper joint tension if the error is not caught.

What You Should Do

Identify if you have the affected UNITRAX Endoprosthesis Head Components by checking the Catalog and Lot Numbers on the packaging.
For the 43mm size (Catalog 6942-5-043), check for Lot Numbers 5Y1350, LN815R, or PV0H60 and GTIN 07613327032376.
For the 42mm size (Catalog 6942-5-042), check for Lot Numbers 4615EX, HE645D, or 8A399N and GTIN 07613327032369.
For the 38mm size (Catalog 6942-5-038), check for Lot Numbers JT38AD or E94VEV and GTIN 07613327032338.
If you are a patient who has undergone a hip procedure involving this device, contact your orthopedic surgeon or healthcare provider to discuss the recall.
Hospitals and surgical centers should immediately quarantine any affected units and contact Howmedica Osteonics Corp. at 325 Corporate Dr, Mahwah, New Jersey, 07430-2006 for return instructions.
For additional questions, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: UNITRAX Endoprosthesis Head Component - 43mm

Model / REF:

6942-5-043

UPC Codes:

07613327032376

Lot Numbers:

5Y1350

LN815R

PV0H60

Product: UNITRAX Endoprosthesis Head Component - 42mm

Model / REF:

6942-5-042

UPC Codes:

07613327032369

Lot Numbers:

4615EX

HE645D

8A399N

Product: UNITRAX Endoprosthesis Head Component - 38mm

Model / REF:

6942-5-038

UPC Codes:

07613327032338

Lot Numbers:

JT38AD

E94VEV

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94871

Status: Active

Manufacturer: Howmedica Osteonics Corp.

Sold By: Hospitals; Surgical Centers

Manufactured In: United States

Units Affected: 3 products (18 units; 18 units; 12 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 · 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

What You Should Do

Identify if you have the affected UNITRAX Endoprosthesis Head Components by checking the Catalog and Lot Numbers on the packaging.

For the 43mm size (Catalog 6942-5-043), check for Lot Numbers 5Y1350, LN815R, or PV0H60 and GTIN 07613327032376.

For the 42mm size (Catalog 6942-5-042), check for Lot Numbers 4615EX, HE645D, or 8A399N and GTIN 07613327032369.

For the 38mm size (Catalog 6942-5-038), check for Lot Numbers JT38AD or E94VEV and GTIN 07613327032338.

If you are a patient who has undergone a hip procedure involving this device, contact your orthopedic surgeon or healthcare provider to discuss the recall.

Hospitals and surgical centers should immediately quarantine any affected units and contact Howmedica Osteonics Corp. at 325 Corporate Dr, Mahwah, New Jersey, 07430-2006 for return instructions.

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

Affected Products

Product: UNITRAX Endoprosthesis Head Component - 43mm

Model / REF:

6942-5-043

UPC Codes:

07613327032376

Lot Numbers:

5Y1350

LN815R

PV0H60

Product: UNITRAX Endoprosthesis Head Component - 42mm

Model / REF:

6942-5-042

UPC Codes:

07613327032369

Lot Numbers:

4615EX

HE645D

8A399N

Product: UNITRAX Endoprosthesis Head Component - 38mm

Model / REF:

6942-5-038

UPC Codes:

07613327032338

Lot Numbers:

JT38AD

E94VEV