Reported Jan 22, 2025 · Ongoing
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
IsoTis OrthoBiologics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: IsoTis OrthoBiologics, Inc. · 2 Goodyear Ste A · Irvine, CA · 92618-2052
Is this the product you have?
OsteoCove Putty1.25ccREF 56920013 and Cove Putty1.25cc REF 02-9200-01
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 5692001310889981309022UDI-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 02-9200-01310889981308933UDI-DI: 10889981308933 — Lot Number: 180075R18, Exp. 2025-08-28. - Amount recalled
- 145
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
This product could cause temporary or reversible health problems — stop using it.
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