- Recalling firm
- Orthorebirth Co Ltd
- Reason for recall
- Resorbable bone void filler falls outside standard specifications.
- Affected products (lot / model / serial)
- UDI-DI: 04573190050552. Lots: 25043001, 25043002, 25043003, 25051401, 25051402, 25051701, 25051702, 25060701, 25060702, 25060703, 25060704, 25083001, 25083002, 25083003, 25083004, 25083005, 25120301, 25122701, 25122702, 26020401 25F07101AA, 25F07103AA, 25F07106AA, 25H27105AA, 25H27107AA, 25H27102AA, 25H27103AA, 25H27104AA, 25K08102AA, 25K08103AA, 25K08101AA, 25J27104AA, 25J27103AA, 25J27102AA, 25J27101AA, 25H27108AA, 25H27101AA
- Units affected
- 1266
- Distribution pattern
- US Nationwide distribution in the states of CA, FL.
- Firm location
- Yokohama, Japan
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2131-2026
- Recall initiated
- March 25, 2026
- FDA classification date
- May 7, 2026
- FDA report date
- May 13, 2026
- FDA event ID
- 98733
- Last updated on HTM Vibe
- July 24, 2026