- Recalling firm
- Orthorebirth Co Ltd
- Reason for recall
- Resorbable bone void filler falls outside standard specifications.
- Affected products (lot / model / serial)
- UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF
- Units affected
- 20
- 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-2132-2026
- 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