Z-0919-2025 Class II Ongoing
FDA device recall Z-0919-2025 was initiated by IsoTis OrthoBiologics, Inc. on November 27, 2024 and is designated Class II. Reason for recall: Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer. The recall status is ongoing. Affected quantity: 145.
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2025
- Initiation Date
- November 27, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 145
Product Description
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Reason for Recall
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Distribution Pattern
US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.
Code Information
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.