OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
This recall is currently active, issued January 15, 2025. It was issued by Isotis Orthobiologics, Inc..
- Company
- Isotis Orthobiologics, Inc.
- Recall Initiated
- November 27, 2024
- Posted
- January 15, 2025
- Recall Number
- Z-0919-2025
- Quantity
- 145
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Distribution
US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.
Lot / Code Info
OsteoCove Putty, REF 56920013, UDI-DI: 10889981309022, Lot Numbers: 180054, Exp. 2025-08-28; 180054R18, Exp. 2025-08-28; 179604R18, Exp. 2024-12-28; 180484, Exp. 2026-02-28; 180370, Exp. 2026-01-28; 180299, Exp. 2025-11-28; 180075, Exp. 2025-08-28; and Cove Putty, REF 02-9200-013, UDI-DI: 10889981308933, Lot Number: 180075R18, Exp. 2025-08-28.
Root Cause
Under Investigation by firm
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.