Class II
Medical Device Recall: OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
IsoTis OrthoBiologics, Inc. · November 27, 2024
Reason for Recall
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Distribution
US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.
States Affected
NATIONWIDE
Quantity Affected
145
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0919-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.