IsoTis OrthoBiologics, Inc.: OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

Hazard

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

Details from the source

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. Quantity: 145 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.

UPC codes

10889981309022, 10889981308933

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.