FDA Medical devices recall ·
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand) recall
- Recall number
- Z-2820-2026
- Date
- (initiated July 2, 2026)
- Company / brand
- IsoTis OrthoBiologics, Inc.
2 Goodyear Ste A, Irvine, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 98
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 02-8000-095/10889981149314/181559, 181550
Distribution
US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
States: Alaska Arkansas California New Jersey Ohio Tennessee Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2820-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.