Z-0955-2025Class II

OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone...

Name: Z-0955-2025 OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone...
Creator: IsoTis OrthoBiologics, Inc.
Published: 2024-11-27
License: https://open.fda.gov/license/

IsoTis OrthoBiologics, Inc. / initiated 2024-11-27 / Open, Classified / root cause: labeling and UDI

FDA source

IsoTis OrthoBiologics, Inc. began a recall of OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100 on 2024-11-27. FDA classified it as Class II and gives the reason as "Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0955-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-27
Posted: 2025-01-16
Recalling firm: IsoTis OrthoBiologics, Inc.
Product: OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Product code: MQV Filler, Bone Void, Calcium Compound
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: An Urgent Medical Device Recall notice was issued via email 11/27/2024. The notice advised consignees to either use the product by the expiration date listed in the notice or return the affected part(s) using provided shipping label and complete and return the Acknowledgement and Receipt Form as soon as possible. Direct questions regarding this matter to Danielle Becker at [email protected] or Danielle Nelson-Archer at [email protected].
Quantity in commerce: 22
Distribution: US Nationwide distribution in the states of IN, TN & TX.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0955-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0955-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-16

Product code MQV

K242273Class IICove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation / cleared 2024-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)