CLASS II ONGOING Device recall · Reported 5 Aug 2026 · FDA Enforcement Report
OsteoBallast, . (SeaSpine Brand) recalled by IsoTis OrthoBiologics
IsoTis OrthoBiologics is recalling OsteoBallast, . (SeaSpine Brand), distributed nationwide in the US. The recall was initiated on 2 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2820-2026
- FDA event ID
- 99332
- Recalling firm
- IsoTis OrthoBiologics, Irvine, CA
- Brand
- SeaSpine
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Jul 2026
- FDA classified
- 28 Jul 2026
- Reported
- 5 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 2 Jul 2026 | Recall initiated by company | |
| 28 Jul 2026 | Classified by FDA | +26 days |
| 5 Aug 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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.
Product as listed by the FDA
OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Where it was distributed
US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
Nationwide AlaskaArkansasCaliforniaNew JerseyOhioTennesseeWashington
Questions about this recall
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.
Which lots are affected?
REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 02-8000-095/10889981149314/181559, 181550
Where was it sold?
US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from IsoTis OrthoBiologics
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OsteoCove Putty, 1.25cc recalled by IsoTis OrthoBiologics | IsoTis OrthoBiologics | Other | Nationwide |
| Device | CLASS II | OsteoSurge 100 Demineralized Bone Matrix Putty recalled | IsoTis OrthoBiologics | Device Malfunction | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |