OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- IsoTis OrthoBiologics, Inc.
- Reason for Recall:
- Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0919-2025
Related Recalls
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
IsoTis OrthoBiologics
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.