DeviceSignal · Recall classified
IsoTis OrthoBiologics, Inc.
FDA classified a device recall on 2026-07-28 · Class II · Z-2820-2026
EventRecall classified
Effective2026-07-28
ClassificationClass II
On 2026-07-28 the FDA classified a device recall from IsoTis OrthoBiologics, Inc. as Class II. Product: OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm…. Recall Z-2820-2026. The firm initiated it on 2026-07-02. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2820-2026
- Classification
- Class II
- Classified on
- 2026-07-28
- Initiated on
- 2026-07-02
- Firm
- IsoTis OrthoBiologics, Inc.
- 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.
- Product
- OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2820-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
30c6301792c114e9feaa216e822bab3f81b3b21222ccce2185bf0828bea3e274- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)