Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OsteoCove Putty Recalled by IsoTis OrthoBiologics, Inc. Due to Hydration issue resulting in the product being less...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact IsoTis OrthoBiologics, Inc. directly.
Affected Products
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Quantity: 145
Why Was This Recalled?
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About IsoTis OrthoBiologics, Inc.
IsoTis OrthoBiologics, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report