Device product
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Z-0919-2025
Product summary
- Event
- Event 95978
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 145
- Official record key
device-enforcement:Z-0919-2025
Official wording
Reason: Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
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.
Distribution pattern: US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.
Derived failure modes
-
Unknown
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.