ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

FDA device recall Z-2132-2026 · posted 2026-05-07 · Open, Classified

Recall details

Recalling firm: Orthorebirth Co Ltd
Reason for recall: Resorbable bone void filler falls outside standard specifications.
Action taken: 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
Root cause: Device Design
Status: Open, Classified
Product code: MQV
Quantity affected: 20
Distribution: US Nationwide distribution in the states of CA, FL.
Date initiated: 2026-03-25
Date posted: 2026-05-07
Location: Yokohama, 3 Chome, Japan

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