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Open, Classified

OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.

FDA Recall Z-0955-2025 · Posted 2025-01-16

Recalling FirmIsoTis OrthoBiologics, Inc.
Recall StatusOpen, Classified
Product CodeMQV
Date Initiated2024-11-27
Product Quantity22

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.

Firm 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].

Root Cause

Labeling Change Control

Distribution Pattern

US Nationwide distribution in the states of IN, TN & TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation · 2024-09-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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