OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc,
Summary
The FDA issued a Class II for OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSur by IsoTis OrthoBiologics, Inc.. Reason: Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray..
Details
Source
Device Recall
External ID
Z-0955-2025
Action Date
2025-01-22
Status
Ongoing
Category
device
Product Description
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Lot/Code Info: UDI-DI: 10889981055820, Lot 1031907, Exp. 2025-11-28 (Inner Tray Exp. 2024-11-28) and Lot 1031825, Exp. 2025-07-28 (Inner tray Exp. 2025-03-28)
Quantity Affected: 22
Reason for Recall
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
Distribution
US Nationwide distribution in the states of IN, TN & TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-27
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 249 device recalls issued in the same week, part of 403 device-related FDA actions this month.
IsoTis OrthoBiologics, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (IsoTis OrthoBiologics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does IsoTis OrthoBiologics, Inc. have FDA actions?
IsoTis OrthoBiologics, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0955-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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