Orthorebirth Co Ltd 3 Chome 17-43 Chigasakihigashi; Tsuzuki Yokohama Japan: Filler, Bone Void, Calcium Compound
- Recalling firm
- Orthorebirth Co Ltd 3 Chome 17-43 Chigasakihigashi; Tsuzuki Yokohama Japan
- Product
- ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
- 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/9ee3b7e1-cefa-402c-b00a-add13bf64afd