OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
FDA device recall Z-0919-2025 · posted 2025-01-15 · Open, Classified
Recall details
- Recalling firm
- IsoTis OrthoBiologics, Inc.
- Reason for recall
- Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MQV
- Quantity affected
- 145
- Distribution
- US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.
- Date initiated
- 2024-11-27
- Date posted
- 2025-01-15
- Location
- Irvine, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Cove Putty, OsteoCove Putty (K242273) | SeaSpine Orthopedics Corporation | 2024-09-25 |