Irvine, CA, United States

IsoTis OrthoBiologics, Inc. recalls

3 recalls recorded since 2018, most recently on 2 July 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.

Recalls3

Ongoing (FDA)3

Terminated or completed0

Class I (FDA)0

Recall started: 2 July 2026
Reason: Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc DBM (fill for 45 ¿ 11 mm configuration) instead of approx. 7.5 cc DBM (fill for 45 ¿ 17.5 mm configuration), which may lead to delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth.
Distribution: US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
Initiated: Voluntary: Firm initiated
Recall number: Z-2820-2026

OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095

Recall started: 27 November 2024
Reason: 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.
Initiated: Voluntary: Firm initiated
Recall number: Z-0955-2025

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

Recall started: 27 November 2024
Reason: Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Distribution: US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.
Initiated: Voluntary: Firm initiated
Recall number: Z-0919-2025

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.