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
- Orthopedic Instruments
- Model numbers
- Lot# 0001, 0002, 0003, 0004, 0005, 0006, 0008, 0009 +12 more
- 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 Medicrea IB3D PL Instruments Set is a specialized tool used in orthopedic surgeries to assist in the placement of implants. Surgeons purchase this device for its precision and reliability during surgical procedures.
Why This Is Dangerous
The defect in the orthopedic rotation tool handle may lead to failure during surgery, compromising patient safety and surgical outcomes. If the handle untreads, the implant cannot be rotated as intended, which is critical for proper placement.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses a significant safety risk, potentially endangering patients during surgical procedures. It requires immediate action from healthcare providers to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Locate the model number on your device.
- Check if the model number matches any listed in the recall.
- If it matches, stop using it immediately.
Where to find product info
The model number can typically be found on the device or its packaging.
What timeline to expect
Expect a refund or resolution within 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Contact the manufacturer again for updates.
- Reach out to your healthcare provider for assistance.
- Consider filing a complaint with the FDA.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Look for safety certifications from manufacturers.
- Consult with healthcare professionals regarding device safety.
Documentation advice
Keep all correspondence related to the recall and take photos of the product and any issues.
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Product Details
The recall involves the Medicrea IB3D PL Instruments Set, Rx Only REF: SPS03174. It includes models Lot# 0001 through 0025. The instruments were distributed nationwide in states including TN, CA, MN, NC, TX, FL, OH, RI, and VA.
Key Facts
- Orthopedic rotation tool handle defect
- Class II recall
- Nationwide distribution in nine states
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Safety Guide
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