IsoTis OrthoBiologics Recalls OsteoBallast Bone Graft Products
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
IsoTis OrthoBiologics, Inc. is recalling 98 units of OsteoBallast and Ballast bone graft products distributed nationwide due to incorrect DBM fill volume.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 13, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
IsoTis OrthoBiologics, Inc. initiated a voluntary recall of certain OsteoBallast and Ballast products because they were filled with approximately 4.5 cc of demineralized bone matrix instead of the intended 7.5 cc. This may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.
Which Products Are Affected
The recall affects 98 units of the following products distributed to US Nationwide in the states of AK, NJ, TN, AR, CA, WA, OH:
- OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095
- Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Affected lots: 181559, 181550 Recall number: Z-2820-2026 Classification: Class II
What You Should Do
Consumers and healthcare providers should follow instructions provided in the firm's notification letter for returns or further guidance.
Why This Matters
The incorrect fill volume in these bone graft extenders indicated for use with autograft in the posterolateral spine and pelvis could result in delayed or incomplete bone fusion.
Source
FDA recall Z-2820-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,080 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 13, 2026.
Frequently Asked Questions
Common questions about this FDA recall.