FDA DeviceClass IINotable

FDA Recall: OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), R

Date: 2026-08-05
Brand: IsoTis OrthoBiologics, Inc.
Category: Medical Device
FDA Class: Class II

Description

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.

Hazard

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.

Remedy

98

View original recall →
Share:

Related Recalls

2026-08-05 · FDA_DEVICE
FDA Recall: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass
Medtronic Perfusion Systems
2026-08-05 · FDA_DEVICE
FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12
Windstone Medical Packaging, Inc.
2026-08-05 · FDA_DEVICE
FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS
Windstone Medical Packaging, Inc.
2026-08-05 · FDA_DEVICE
FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part
Windstone Medical Packaging, Inc.