FDA recall, , Moderate risk
SeaSpine OsteoBallast and Ballast Bone Grafts
The products were filled with approximately 4.5 cc DBM instead of approximately 7.5 cc DBM.
Summary by Recall Canary from the FDA notice
What happened
IsoTis OrthoBiologics, Inc., of Irvine, California, began a recall on July 2, 2026, for OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095, and Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095. These demineralized bone matrix products in resorbable mesh are indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis.
The products were filled with approximately 4.5 cc DBM instead of approximately 7.5 cc DBM, which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth. The FDA added the recall to its Enforcement Report and classified it on July 28, 2026, with distribution in Alaska, Arkansas, California, New Jersey, Ohio, Tennessee, and Washington.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
- UDI-DI
- 56800095
- 10889981149352
- 10889981149314
- Lot code
- 181559
- 181550
- 02-8000-095
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Alaska, New Jersey, Tennessee, Arkansas, California, Washington, Ohio.
- Company
- IsoTis OrthoBiologics, Inc.Irvine, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99332
- Recall number
- Z-2820-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
