Quick Facts at a Glance
- Recall Date
- December 19, 2025
- Hazard Level
- HIGH
- Brand
- MicroPort Orthopedics
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- MicroPort Orthopedics
- Product type
- Surgical Device
- Model numbers
- Lot Code: Part Number HTHT0036, all lots, no future lots planned. Primary DI Number 00192629320130. Secondary Device ID M684HTHT00361
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 19, 2025
Reported by FDA DEVICE
January 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to products not having FDA Premarket authorization to be distributed within the United States.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact MicroPort Orthopedics Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The HIPTURN Fem Head Trial device is used in orthopedic procedures to assist in surgical planning and execution. Healthcare providers utilize such devices to ensure precision during surgeries.
Why This Is Dangerous
The lack of FDA premarket authorization raises serious concerns about the safety and efficacy of the device. Without proper evaluation, there is no assurance of its performance or potential risks to patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall places a significant burden on healthcare providers who must stop using the device, potentially disrupting surgical schedules and leading to delays in treatment.
Practical Guidance
How to identify if yours is affected
- Check the model number on your device to see if it is HTHT0036.
- Verify the lot code against the recall information provided by MicroPort Orthopedics.
- Contact your distributor for confirmation on your device's status.
Where to find product info
The lot codes and model number can typically be found on the packaging or the device itself.
What timeline to expect
Expect a processing time of 4-6 weeks for any refund or replacement from MicroPort Orthopedics.
If the manufacturer is unresponsive
- Document all communications with MicroPort Orthopedics.
- Reach out to the FDA for additional guidance or to file a complaint.
How to prevent similar issues
- Always ensure medical devices are FDA-approved before use.
- Consult with healthcare providers about the safety evaluations of surgical tools.
- Stay informed about recalls in the medical device industry.
Documentation advice
Keep records of your purchase, any communication from the manufacturer, and details regarding the device for your records.
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Product Details
The recalled product is the HIPTURN Fem Head Trial 36mm Reusable, model number HTHT0036. It was distributed to various states including Texas, California, and Wisconsin, as well as internationally to countries like Belgium and Japan.
Key Facts
- Distributed to multiple U.S. states and countries
- No reported incidents or injuries
- Stop using the device immediately
- Contact MicroPort for instructions
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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