- Recalling firm
- IsoTis OrthoBiologics, Inc.
- Reason for recall
- Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿ 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 ¿ 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.
- Affected products (lot / model / serial)
- REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 02-8000-095/10889981149314/181559, 181550
- Units affected
- 98
- Distribution pattern
- US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
- Firm location
- Irvine, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2820-2026
- Recall initiated
- July 2, 2026
- FDA classification date
- July 28, 2026
- FDA report date
- August 5, 2026
- FDA event ID
- 99332
- Last updated on HTM Vibe
- August 11, 2026