Recall Z-0919-2025 ยท MQV Filler, Bone Void, Calcium Compound
IsoTis OrthoBiologics, Inc.
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
| Date | Jan 15, 2025 (initiated Nov 27, 2024) |
| Status | Open, Classified |
| Reason | Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Recall notice dated 11/27/2024 was issued via email. The notice advises customers to discontinue use, review inventory on hand for the referenced lots, and return the affected part(s) to SeaSpine using the attached label to return the inventory. Once inventory has been returned, please acknowledge via DocuSign. Direct questions regarding this matter to Danielle Becker at danielle.becker@seaspine.com or Danielle Nelson-Archer at danielle.nelson-archer@seaspine.com. |
| Quantity | 145 |
| Distribution | US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, 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 |