Lower risk Medical device recall · FDA · Published July 2, 2026

IsoTis OsteoBallast Spine Implants Risk of Delayed Bone Fusion

IsoTis recalls OsteoBallast 45x17.5mm implants that may cause delayed or failed spinal fusion due to incorrect bone matrix fill. Affected units have specific reference numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2820-2026Medical device IsoTis ›

Lower-risk 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.

✎ GovInfoNow plain-language explainer

IsoTis recalls certain OsteoBallast spinal implants that contain too little demineralized bone matrix (DBM) than specified. This could lead to delayed or failed spinal fusion, causing pain and requiring additional surgery. Read more at govinfonow.com/recall/169197-isotis-osteoballast-spine-implants-risk-of-delayed-bone-fusion.

Source Summary by GovInfoNow · govinfonow.com/recall/169197-isotis-osteoballast-spine-implants-risk-of-delayed-bone-fusion · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2820-2026

Cite this page

“IsoTis OsteoBallast Spine Implants Risk of Delayed Bone Fusion.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/169197-isotis-osteoballast-spine-implants-risk-of-delayed-bone-fusion. Based on FDA recall #Z-2820-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2820-2026%22&limit=1).

The FDA announced on July 2, 2026, that IsoTis OrthoBiologics, Inc. is recalling OsteoBallast ballast devices due to an incorrect fill volume of demineralized bone matrix. This error may lead to delayed or incomplete fusion in patients. The recall was initiated voluntarily by the firm.

How to tell if you have it

Brand: IsoTis
Product: Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095; Lots: 181559, 181550
Brand: SeaSpine
Product: OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095; Lots: 181559, 181550

The hazard

The demineralized bone matrix in the resorbable mesh was filled with approximately 4.5 cc instead of the required 7.5 cc for the 45 x 17.5 mm configuration. According to the FDA, this deficiency may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.

Context

GovInfoNow's records show IsoTis OrthoBiologics, Inc. has two other recalls on record since November 27, 2024. On November 27, 2024, the company recalled OsteoCove Putty due to a hydration issue and OsteoSurge Bone Matrix Putty for an incorrect expiration date on packaging. Other recent recalls of similar products include Orthorebirth BioCera Fibers Bone Filler Recall (March 25, 2026).

How to tell if you have this one

Check for the product name 'OsteoBallast' with size 45 x 17.5 mm. The reference numbers include 56800095 for SeaSpine Brand and 02-8000-095 for IsoTis Brand.

Brand
IsoTis
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the reference number on the implant packaging or label to confirm if it matches the recalled units.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 7 states.

FDA distribution: “US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alaska, Arkansas, California, New Jersey, Ohio, Tennessee, Washington.

Recall timeline

FDA published this recall 34 days after the firm started it.

Jul 2, 2026Firm started the recall
Jul 28, 2026FDA classified it Class II
Aug 5, 2026Published in FDA’s Enforcement Report
Aug 11, 2026Added to GovInfoNow

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/169197-isotis-osteoballast-spine-implants-risk-of-delayed-bone-fusion">IsoTis OsteoBallast Spine Implants Risk of Delayed Bone Fusion (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2820-2026 (July 2, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2820-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.