medical Class II Updated 2025-01-22

IsoTis OrthoBiologics, Inc. recalls OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc

Recalled Product

OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.


Hazard / Issue

Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.

Issued by

FDA

Distribution: Nationwide (United States)
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.
View official government recall

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