Recall Z-2820-2026 ยท MQV Filler, Bone Void, Calcium Compound
IsoTis OrthoBiologics, Inc.
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
| Date | Jul 28, 2026 (initiated Jul 2, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | On 7/2/2026, recall notices were emailed to customers informing them of the following: Orthofix does not recommend removal or revision of implanted devices containing product from the affected lots. Patients should continue to be managed according to the treating surgeon's standard clinical practice and routine follow-up schedule. Surgeons should monitor for signs or symptoms consistent with delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth and manage patients as clinically indicated. If the procedure was performed in accordance with the surgical technique and the i |
| Quantity | 98 |
| Distribution | US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172130 | Resorbable Mesh Device SeaSpine Orthopedics Corporation, Nov 16, 2017 |