Recall Z-2132-2026— Orthorebirth Co Ltd
Class II · Ongoing
Class II FDA medical device recall by Orthorebirth Co Ltd, initiated 2026-03-25. It names 3 FDA 510(k) clearances: K240453, K172573, K170620. Product: ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z. Reason: Resorbable bone void filler falls outside standard specifications..
- Recalling firm
- Orthorebirth Co Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-03-25
- Firm location
- Yokohama, Japan
510(k) clearances named in this recall
3 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Reason for recall
Resorbable bone void filler falls outside standard specifications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.