Quick Facts at a Glance
- Recall Date
- July 28, 2025
- Hazard Level
- HIGH
- Brand
- Ortoma
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- 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
- Ortoma
- Product type
- Inserter Adapter
- Model numbers
- 2001, 1001, 1003, 1004
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 28, 2025
Reported by FDA DEVICE
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to a weld breakage between the pin and inserter holder of the Inserter Adapter.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ORTOMA AB or your healthcare provider for instructions. Notification method: Letter
About This Product
This device set is used to attach to a Cup Inserter Tool during hip replacement surgery to guide alignment of the implant cup.
Why This Is Dangerous
A weld break between the pin and inserter holder can cause misalignment of the hip cup during implantation, potentially affecting outcomes.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
The recall may affect surgical workflows and necessitate recalling and replacing affected adapters to ensure proper cup placement.
Practical Guidance
How to identify if yours is affected
- Inspect packaging and labels for the Ortoma Inserter Adapters used with Cup Inserter Tools.
Where to find product info
UDI-DI codes and model numbers on device labeling and packaging; recall notice from Ortoma AB and FDA page.
What timeline to expect
Remedy processing and replacement or instructions may take several weeks; follow manufacturer guidance.
If the manufacturer is unresponsive
- Document all contact attempts with Ortoma AB and healthcare providers.
- If no response within a reasonable period, contact your local health authority or regulatory agency for guidance.
How to prevent similar issues
- Verify device UDI-DI codes before use in surgery.
- Ensure you are using non-recalled adapters as instructed by the manufacturer.
- Maintain updated recall communications and facility procedures for device recalls.
Documentation advice
Save recall notice, product labels, UDI-DI codes, and all correspondence with Ortoma AB or healthcare providers.
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Product Details
Models: 2001, 1001, 1003, 1004. UDI-DI codes: 07350137521019; 07350137520593; 07350137520081; 07350137520098. Distribution: Worldwide; U.S. Florida; Japan; Sweden. Recall date: 2025-07-28. Quantity: 261 devices. Classification: Class II. Remed y: Stop using the device and follow manufacturer instructions. Brand: Ortoma AB.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- UDI-DI codes listed for all models
- Worldwide distribution with Florida, Japan and Sweden mentioned
- High-hazard Class II recall
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