Quick Facts at a Glance
- Recall Date
- September 11, 2025
- Hazard Level
- HIGH
- Brand
- Theken Companies
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- Theken Companies
- Product type
- Bipolar Head Assembly
- Model numbers
- 10-22-0038, 10-22-0040, 10-22-0042, 10-22-0044, 10-22-0046, 10-22-0048, 10-22-0050, 10-22-0052
- Sizes
- 38mm, 40mm, 42mm, 44mm, 46mm +7 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 11, 2025
Reported by FDA DEVICE
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Theken Companies LLC or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
The iNSitu Bipolar Hip System is used in hip replacement procedures. The bipolar head assembly is a component that articulates with the acetabular cup during joint replacement.
Why This Is Dangerous
A transit testing failure raises concerns about the sterile barrier integrity. If the barrier is breached, there is a risk of infection or implant-associated complications.
Industry Context
This recall is not indicated as part of a broader industry pattern.
Real-World Impact
Hospitals and patients may experience delays in device availability and require medical team coordination to replace affected components. No injuries have been reported yet.
Practical Guidance
How to identify if yours is affected
- Review model numbers 10-22-0038 through 10-22-0052 in your inventory.
Where to find product info
UDI-DI numbers and lot codes are printed on device packaging and labeling. Model numbers are on the device itself or accompanying documentation.
What timeline to expect
Recall processing and notices are expected to continue in the coming weeks. Recipients should follow the manufacturer’s instructions and coordinate in
If the manufacturer is unresponsive
- Escalate to hospital risk management or the FDA recall hotline if the manufacturer is not responsive.
- Consider contacting state health authorities if necessary.
How to prevent similar issues
- Verify UDI-DI against recall lists before using hip implant components.
- Maintain an updated inventory of hip prosthesis components and their recall status.
- Coordinate with procurement to retire affected stock and obtain compliant replacements.
Documentation advice
Document all recall communications, inventory recalls, and any patient-level actions taken. Retain photos, letters, and receipts related to the recall.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US nationwide distribution; NJ, PA, TX
- Recall date 2025-09-11; Report date 2025-10-29
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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