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IsoTis OrthoBiologics, Inc. recalls OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Recalled January 22, 2025 · FDA recall Z-0919-2025 · IsoTis OrthoBiologics
Hazard
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer. · FDA Class II
Units
145
Sold at
US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.
Description
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Product
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Manufacturer(s)
IsoTis OrthoBiologics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →