Zenbone, Ref: Orb-0320c-Z, Orb-0310c-Z, Orb-0304c-Z recallZ-2132-2026 · Orthorebirth Co Ltd · initiated Mar 25, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Orthorebirth Co Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Resorbable bone void filler falls outside standard specifications.
FDA root cause category: Device Design
What the company is doing
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 [email protected] If you have recall questions, an alternative firm contact for the recall can be found at 1-858-792-1235
Recall details
- Recall number
- Z-2132-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 25, 2026
- Posted by the FDA
- May 7, 2026
- Recalling firm
- Orthorebirth Co Ltd
- Quantity
- 20
- Product code
- MQV
- FDA submissions
- K170620, K172573, K240453
- Distribution
- US Nationwide distribution in the states of CA, FL.
Product description
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Code information (models, lots, serial numbers)
UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ZENBONE 0.4gOrthorebirth CO.,Ltd. · Filler, Bone Void, Calcium Compound1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98733).
- Z-2131-2026 · Open, ClassifiedBioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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