Recipient Title Vice President and General Manager of Spine Operations, IsoTis OrthoBiologics, Inc., 2 Goodyear, Ste A, Irvine , CA 92618 United States, (b)(4)Issued Feb 24, 2026Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations3
Issue DateFeb 24, 2026
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
IsoTis OrthoBiologics, Inc.
Location
Recipient Title Vice President and General Manager of Spine Operations, IsoTis OrthoBiologics, Inc., 2 Goodyear, Ste A, Irvine , CA 92618 United States, (b)(4)
FEI Number
N/A
Country
United States
Issue Date
February 24, 2026
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Open
Subject
CGMP/QSR/Medical Devices/Adulterated
IsoTis OrthoBiologics, Inc. FDA Warning Letter, February 24, 2026
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