Orthorebirth Co Ltd recalls ZENBONE

Resorbable bone void filler falls outside standard specifications.

On 3/25/2026, product withdrawal emails were sent to customers informing them to stop distribution and that additional information on device return would be provided. If products were distributed to distributors or hospitals, the firm requests the customer inform to stop distribution and ensure affected devices are not used. In addition, notify the firm if affected devices were used in surgery. On 4/21/2026, recall notices were emailed to customers who were asked to do the following: 1) Return affected devices to firm. 2) If devices were distributed elsewhere, recover all affected product that is in the hands of sub-distributors or end-users, and that you return all affected product to firm. 3) Complete and return the customer reply form via email to return@orthorebirth.com If you have recall questions, an alternative firm contact for the recall can be found at 1-858-792-1235

• FDA enforcement recordOfficial FDA database entry for Z-2132-2026
• FDA 510(k) clearance · K170620The device's official FDA premarket clearance record
• FDA 510(k) clearance · K172573The device's official FDA premarket clearance record
• FDA 510(k) clearance · K240453The device's official FDA premarket clearance record
• FDA device classification · MQVOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3045The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Orthorebirth Co LtdSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.