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U.S. Department of Health and Human Services

Class 2 Device Recall Zenbone

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 Class 2 Device Recall Zenbonesee related information
Date Initiated by FirmMarch 25, 2026
Date PostedMay 07, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2132-2026
Recall Event ID 98733
510(K)NumberK170620 K172573 K240453 
Product Classification Filler, bone void, calcium compound - Product Code MQV
ProductZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Code Information UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF
FEI Number 3011415547
Recalling Firm/
Manufacturer		 Orthorebirth Co Ltd
3 Chome 17-43
Chigasakihigashi; Tsuzuki
Yokohama Japan
Manufacturer Reason
for Recall		Resorbable bone void filler falls outside standard specifications.
FDA Determined
Cause 2		Device Design
ActionOn 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
Quantity in Commerce20
DistributionUS Nationwide distribution in the states of CA, FL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MQV
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