Quick Facts at a Glance
- Recall Date
- August 28, 2025
- Hazard Level
- HIGH
- Brand
- Howmedica Osteonics
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Howmedica Osteonics
- Product type
- Surgical Stem
- Model numbers
- Catalog Number: 0580-1-442, Catalog Number: 0580-1-352, UDI-DI: 04546540153319, UDI-DI: 04546540153241
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 28, 2025
Reported by FDA DEVICE
October 8, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Howmedica Osteonics Corp. or your healthcare provider for instructions. Notification method: Letter
About This Product
The EXETER V40 surgical stem is used in hip replacement surgeries, designed to provide stable and long-lasting support for hip implants. They are critical for patients undergoing hip surgeries and are typically used in conjunction with specific hip joint implants.
Why This Is Dangerous
The hazard arises from a mix-up in packaging where one catalog number may contain the other model. Patients receiving the incorrect implant could face serious surgical complications or implant failure.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must address the recall promptly to prevent any potential surgical complications due to incorrect implant usage.
Practical Guidance
How to identify if yours is affected
- Check your implant for the catalog number: 0580-1-442 or 0580-1-352.
- Verify your UDI-DI and lot numbers to ensure they match the recalled products.
- Contact your healthcare provider for further assessment.
Where to find product info
Catalog numbers and lot information can typically be found on the product packaging or directly on the device itself.
What timeline to expect
Expect a refund processing timeline of about 4-8 weeks after returning the product.
If the manufacturer is unresponsive
- Document all communications with the company regarding your recall inquiry.
- Follow up via email or phone if you do not receive a timely response.
- Consider filing a complaint with the relevant health authority if issues persist.
How to prevent similar issues
- Always verify catalog numbers when purchasing medical devices.
- Look for safety certifications and recall history from manufacturers before use.
- Consult healthcare providers regularly about device recalls affecting preparations.
Documentation advice
Keep records of your device details, purchase information, and any correspondence related to the recall.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
1. Catalog Number: 0580-1-442, Lot Number: A00976 2. Catalog Number: 0580-1-352, Lot Number: G8754849 3. Distributed in the United Kingdom only. 4. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distributed in United Kingdom
- Stop using immediately
- Follow manufacturer instructions for return
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.