FDA Medical devices recall ·
OsteoCove Putty, 1.25cc recall
- Recall number
- Z-0919-2025
- Date
- (initiated November 27, 2024)
- Company / brand
- IsoTis OrthoBiologics, Inc.
2 Goodyear Ste A, Irvine, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 145
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Why was it recalled?
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.
States: Alabama California Maryland Minnesota Mississippi North Carolina Nevada Ohio Oklahoma Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0919-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.