OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
This recall is currently active, issued January 16, 2025. It was issued by Isotis Orthobiologics, Inc..
- Company
- Isotis Orthobiologics, Inc.
- Recall Initiated
- November 27, 2024
- Posted
- January 16, 2025
- Recall Number
- Z-0955-2025
- Quantity
- 22
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution in the states of IN, TN & TX.
Lot / Code Info
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)
Root Cause
Labeling Change Control
Action Taken
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.