Orthorebirth Co Ltd 3 Chome 17-43 Chigasakihigashi; Tsuzuki Yokohama Japan: Filler, Bone Void, Calcium Compound
Recall Summary Orthorebirth Co Ltd is recalling BioCera Fibers bone void filler products (multiple reference numbers) because the material does not meet standard quality specifications. The affected products were distributed nationwide in the United States. This is classified as a Class II recall, which indicates a potential health risk.
- Recalling firm
- Orthorebirth Co Ltd 3 Chome 17-43 Chigasakihigashi; Tsuzuki Yokohama Japan
- Product
- BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
- Reason
- Resorbable bone void filler falls outside standard specifications.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-25
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of CA, FL.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e3c0497c-8091-4cb4-8b74-728c532eb011