OsteoCove Putty recalled over mold contamination

Recall date: November 27, 2024
Source: U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title: IsoTis OrthoBiologics, Inc. recalls OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Recall number: Z-0919-2025
FDA classification: Class II
Brand / firm: IsoTis OrthoBiologics, Inc.
Sold / distributed: US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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

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