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U.S. Department of Health and Human Services

Class 2 Device Recall OsteoSurge 100 Demineralized Bone Matrix Putty

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 Class 2 Device Recall OsteoSurge 100 Demineralized Bone Matrix Puttysee related information
Date Initiated by FirmNovember 27, 2024
Date PostedJanuary 16, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0955-2025
Recall Event ID 95981
510(K)NumberK242273 
Product Classification Filler, bone void, calcium compound - Product Code MQV
ProductOsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Code Information 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)
FEI Number 3001503333
Recalling Firm/
Manufacturer		 IsoTis OrthoBiologics, Inc.
2 Goodyear Ste A
Irvine CA 92618-2052
For Additional Information ContactSeaSpine Complaints
760-216-5122
Manufacturer 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.
FDA Determined
Cause 2		Labeling Change Control
ActionAn 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 danielle.becker@seaspine.com or Danielle Nelson-Archer at danielle.nelson-archer@seaspine.com.
Quantity in Commerce22
DistributionUS Nationwide distribution in the states of IN, TN & TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MQV
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