Z-2820-2026 Class II Ongoing
FDA device recall Z-2820-2026 was initiated by IsoTis OrthoBiologics, Inc. on July 2, 2026 and is designated Class II. 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 ¿ … The recall status is ongoing. Affected quantity: 98.
Recall Details
- Product Type
- Devices
- Report Date
- August 5, 2026
- Initiation Date
- July 2, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98
Product Description
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
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.
Distribution Pattern
US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
Code Information
REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 02-8000-095/10889981149314/181559, 181550