Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- Medicrea
- 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
- Medicrea
- Product type
- Implant Inserter
- Model numbers
- Lot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 29, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medicrea International or your healthcare provider for instructions. Notification method: Letter
About This Product
The IB3D Universal Implant Inserter is used in orthopedic procedures to assist with the placement of implants. Surgeons rely on this tool to rotate implants accurately during operations, making it essential for successful outcomes.
Why This Is Dangerous
The handle of the inserter may untread from the shaft, leading to a failure in the device's ability to rotate implants as intended. This can create serious complications during surgical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects the safety and reliability of surgical procedures involving implants. Patients and healthcare providers may experience delays in surgeries while seeking alternative tools.
Practical Guidance
How to identify if yours is affected
- Check the model number and lot information on the device.
- Verify if your device matches the recalled units listed by Medicrea.
- Review any correspondence from Medicrea regarding the recall.
Where to find product info
Model numbers and lot information can typically be found on the device packaging or the device itself.
What timeline to expect
Expect a refund or replacement processing time of about 4 to 6 weeks.
If the manufacturer is unresponsive
- Document all attempts to contact Medicrea.
- Reach out to your healthcare provider for assistance.
- Consider contacting the FDA if the issue persists.
How to prevent similar issues
- Look for devices with strong safety ratings and certifications.
- Research manufacturer histories before purchase.
- Consult with professionals regarding the latest safety recalls.
Documentation advice
Keep records of your purchase, any correspondence with Medicrea, and photos of the device as evidence.
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Product Details
The recalled product is the IB3D Universal Implant Inserter, REF: A24000000. It was distributed nationwide in states such as Tennessee, California, Minnesota, and Texas. The model numbers include Lot# 21J0410, 21J0414, 21J0418, and others.
Key Facts
- Patients should stop using the device immediately
- Handle may untread from the shaft
- Distributed in multiple states
- Contact Medicrea for instructions
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Safety Guide
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