BioCera Fibers Bioresorbable Bone Void Filler Recall
Orthorebirth Co Ltd is recalling BioCera Fibers, a bioresorbable bone void filler, because the product falls outside standard specifications. The recall affects 1266 units distributed nationwide in California and Florida.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall. The product falls outside standard specifications, which constitutes a risk-of-harm scenario for an implantable device. No reported illnesses or injuries are stated in the source text, but the deviation from specifications for a bone void filler presents potential patient risk.
Plain-English summary
Orthorebirth Co Ltd is recalling BioCera Fibers, Bioresorbable Bone Void Filler (reference numbers ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, and ORB-0305D-KC). The product is falling outside standard specifications.
A total of 1266 units have been distributed nationwide in California and Florida. The affected lots are identified by UDI-DI: 04573190050552 and include numerous lot numbers ranging from 25043001 through 26020401 and additional designated lots (25F07101AA, 25F07103AA, 25F07106AA, 25H27105AA, 25H27107AA, 25H27102AA, 25H27103AA, 25H27104AA, 25K08102AA, 25K08103AA, 25K08101AA, 25J27104AA, 25J27103AA, 25J27102AA, 25J27101AA, 25H27108AA, and 25H27101AA).
Healthcare providers and patients who have this product should contact Orthorebirth Co Ltd for further instructions regarding the recall.
The recalled product
- Product
- BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
- Manufacturer
- Orthorebirth Co Ltd
- Hazard
- specification-deviation
- medical-device-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.