Recall Z-0955-2025 ยท MQV Filler, Bone Void, Calcium Compound
IsoTis OrthoBiologics, Inc.
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
| Date | Jan 16, 2025 (initiated Nov 27, 2024) |
| Status | Open, Classified |
| Reason | Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 22 |
| Distribution | US Nationwide distribution in the states of IN, TN & TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242273 | Cove Putty, OsteoCove Putty SeaSpine Orthopedics Corporation, Sep 25, 2024 |