Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot# 0001, 0002, 0003, 0004, 0005, 0006, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0016 ,0017 ,0018, 0020, 0021, 0024, 0025, 0026, 0029/UDI: SPS03174
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medicrea International
- Reason for Recall:
- Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Product Codes/Lot Numbers:
Lot# 0001, 0002, 0003, 0004, 0005, 0006, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0016 ,0017 ,0018, 0020, 0021, 0024, 0025, 0026, 0029/UDI: SPS03174
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1039-2026
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