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OsteoSurge 100 Putty 56300100Recalls & reported problems

Isotis Orthobiologics, Inc. · OsteoSurge100, 10cc - demineralized human bone mixed with poloxamer reverse phase medium. OsteoSurge100 is formulated into a putty form and is provided in a sterile, single use package · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Nov 27, 2024Open, Classified

    Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.

    Z-0955-2025 · Root cause: Labeling Change Control · FDA record ↗

Other FILLER, BONE VOID, CALCIUM COMPOUND devices

All FILLER, BONE VOID, CALCIUM COMPOUND devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.