FDA recall Z-0919-2025

IsoTis OrthoBiologics, Inc. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-11-27
Report date
2025-01-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0919-2025