IsoTis OrthoBiologics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0919-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 27, 2024

Date Posted: January 22, 2025

Recall Number: Z-0919-2025

Event ID: 95978

Reason for Recall:

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

Status: Ongoing

Product Quantity: 145

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.

Voluntary or Mandated:

Voluntary: Firm initiated