FDA-Device2025-01-22Class II
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
IsoTis OrthoBiologics, Inc.
Hazard
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Sold states
US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.
Affected count
145
Manufactured in
2 Goodyear Ste A, Irvine, CA, United States
Products
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0919-2025Don't want to check this manually?
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