EXETER recallZ-2640-2025 · Howmedica Osteonics Corp. · initiated Aug 28, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
On August 28, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions Needed: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. Please assist us in meeting our regulatory obligation by emailing back the attached Urgent Medical Device Recall Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site. Under 21 CFR 803, manufacturers are also required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Stryker informed of any adverse events associated with this product by emailing [email protected]. We regret any inconvenience this action may cause. If you have any questions or concerns after reviewing this letter, please contact Customer Service at (201) 831-5000. For questions pertaining to the recall, email [email protected]
Recall details
- Recall number
- Z-2640-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 28, 2025
- Posted by the FDA
- Sep 26, 2025
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 55 units (all OUS)
- Product code
- JDI
- FDA submissions
- K193429
- Distribution
- International distribution in the country of United Kingdom.
Product description
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
Code information (models, lots, serial numbers)
1. Model/Catalog Number: 0580-1-442, UDI-DI: 04546540153319, Lot Number: A00976; 2. Model/Catalog Number: 0580-1-352, UDI-DI: 04546540153241, Lot Number: G8754849;
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- EXETER 0580-1-442Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall46 reports
- EXETER 0580-1-352Howmedica Osteonics Corp. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 recall23 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page