OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc,
FDA device recall Z-0955-2025 · posted 2025-01-16 · Open, Classified
Recall details
- Recalling firm
- IsoTis OrthoBiologics, Inc.
- 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.
- 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.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- MQV
- Quantity affected
- 22
- Distribution
- US Nationwide distribution in the states of IN, TN & TX.
- Date initiated
- 2024-11-27
- Date posted
- 2025-01-16
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Cove Putty, OsteoCove Putty (K242273) | SeaSpine Orthopedics Corporation | 2024-09-25 |