Recall Z-2131-2026— Orthorebirth Co Ltd

Name: FDA recall Z-2131-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-25

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: 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..

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 record

K240453 — ReBOSSISOrthorebirth Co., Ltd.·cleared 2024-03-04
K172573 — ReBOSSIS85Orthorebirth Co., Ltd.·cleared 2017-12-15
K170620 — ReBOSSIS85Orthorebirth Co., Ltd.·cleared 2017-06-23

K-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

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

Reason for recall

Resorbable bone void filler falls outside standard specifications.

Data sourced from openFDA. This site is unofficial and independent of the FDA.