CLASS II ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
OsteoSurge 100 Demineralized Bone Matrix Putty recalled
IsoTis OrthoBiologics is recalling OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100, distributed nationwide in the US. The recall was initiated on 27 Nov 2024 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-0955-2025
- FDA event ID
- 95981
- Recalling firm
- IsoTis OrthoBiologics, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Nov 2024
- FDA classified
- 16 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 27 Nov 2024 | Recall initiated by company | |
| 16 Jan 2025 | Classified by FDA | +50 days |
| 22 Jan 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Where it was distributed
US Nationwide distribution in the states of IN, TN & TX.
Questions about this recall
Is OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 recalled?
Yes. IsoTis OrthoBiologics recalled OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 on 27 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-0955-2025.
Why was it recalled?
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
Which lots are affected?
UDI-DI: 10889981055820, Lot 1031907, Exp. 2025-11-28 (Inner Tray Exp. 2024-11-28) and Lot 1031825, Exp. 2025-07-28 (Inner tray Exp. 2025-03-28)
Where was it sold?
US Nationwide distribution in the states of IN, TN & TX.
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 21 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 | OsteoBallast, mm (SeaSpine Brand) recalled by IsoTis OrthoBiologics | IsoTis OrthoBiologics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | OsteoCove Putty, 25cc recalled by IsoTis OrthoBiologics | IsoTis OrthoBiologics | Other | Nationwide |
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