🔍 RecallPedia

BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC

Class I - Dangerous
🏥 Medical Devices Recalled: March 25, 2026 Orthorebirth Co Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 04573190050552. Lots: 25043001, 25043002, 25043003, 25051401, 25051402, 25051701, 25051702, 25060701, 25060702, 25060703, 25060704, 25083001, 25083002, 25083003, 25083004, 25083005, 25120301, 25122701, 25122702, 26020401 25F07101AA, 25F07103AA, 25F07106AA, 25H27105AA, 25H27107AA, 25H27102AA, 25H27103AA, 25H27104AA, 25K08102AA, 25K08103AA, 25K08101AA, 25J27104AA, 25J27103AA, 25J27102AA, 25J27101AA, 25H27108AA, 25H27101AA
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Orthorebirth Co Ltd
Reason for Recall:
Resorbable bone void filler falls outside standard specifications.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC

Product Codes/Lot Numbers:

UDI-DI: 04573190050552. Lots: 25043001, 25043002, 25043003, 25051401, 25051402, 25051701, 25051702, 25060701, 25060702, 25060703, 25060704, 25083001, 25083002, 25083003, 25083004, 25083005, 25120301, 25122701, 25122702, 26020401 25F07101AA, 25F07103AA, 25F07106AA, 25H27105AA, 25H27107AA, 25H27102AA, 25H27103AA, 25H27104AA, 25K08102AA, 25K08103AA, 25K08101AA, 25J27104AA, 25J27103AA, 25J27102AA, 25J27101AA, 25H27108AA, 25H27101AA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2131-2026

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