IsoTis OrthoBiologics, Inc.: Device Recall

Recall #Z-0919-2025 · 11/27/2024

Class II: Risk

Recall Details

Recall Number: Z-0919-2025
Classification: Class II
Product Type: Device
Recalling Firm: IsoTis OrthoBiologics, Inc.
Status: Ongoing
Date Initiated: 11/27/2024
Location: Irvine, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 145

Reason for Recall

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

Product Description

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

Distribution Pattern

US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.

Other Recalls by IsoTis OrthoBiologics, Inc.

Class II: Risk 11/27/2024

Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.

View all recalls by IsoTis OrthoBiologics, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.