Recall Z-2820-2026— IsoTis OrthoBiologics, Inc.

Name: FDA recall Z-2820-2026
Creator: U.S. Food and Drug Administration
Published: 2026-07-02

Class II · Ongoing

Class II FDA medical device recall by IsoTis OrthoBiologics, Inc., initiated 2026-07-02. It names one FDA 510(k) clearance: K172130. Product: OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095. 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..

Recalling firm: IsoTis OrthoBiologics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-07-02
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K172130 — Resorbable Mesh DeviceSeaSpine Orthopedics Corporation·cleared 2017-11-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.