OsteoSurge Bone Matrix Putty (IsoTis) – Incorrect Expiration (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Brand
IsoTis OrthoBiologics, Inc.
Lot Codes / Batch Numbers
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)
Products Sold
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)
IsoTis OrthoBiologics, Inc. is recalling OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized due to Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
Recommended Action
Per FDA guidance
An Urgent Medical Device Recall notice was issued via email 11/27/2024. The notice advised consignees to either use the product by the expiration date listed in the notice or return the affected part(s) using provided shipping label and complete and return the Acknowledgement and Receipt Form as soon as possible. Direct questions regarding this matter to Danielle Becker at danielle.becker@seaspine.com or Danielle Nelson-Archer at danielle.nelson-archer@seaspine.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026