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

FDA device recall Z-2820-2026 · posted 2026-07-28 · Open, Classified

Recall details

Recalling firm

IsoTis OrthoBiologics, Inc.

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.

Action taken

On 7/2/2026, recall notices were emailed to customers informing them of the following: Orthofix does not recommend removal or revision of implanted devices containing product from the affected lots. Patients should continue to be managed according to the treating surgeon's standard clinical practice and routine follow-up schedule. Surgeons should monitor for signs or symptoms consistent with delayed fusion, incomplete fusion, pseudarthrosis, or lack of bone ingrowth and manage patients as clinically indicated. If the procedure was performed in accordance with the surgical technique and the intended intraoperative objectives were achieved, no additional patient management beyond routine postoperative care and clinical follow-up described in the Instructions for Use is recommended. The standard postoperative precautions described in the Instructions for Use, including activity restrictions and weight-bearing recommendations, should continue to be followed at the discretion of the treating surgeon. 1) Identify, and quarantine unused product and work with firm to facilitate product return. 2) Complete and return the attached Acknowledgement and Receipt Form 3) This recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. Any product complaints should be reported to Orthofix at complaints@orthofix.com. For questions regarding this recall, including product return, replacement, or credit, please contact Audrey Mudderman, Senior Post Market Surveillance Specialist, at audreymudderman@orthofix.com

Root cause

Process control

Status

Open, Classified

Product code

MQV

Quantity affected

98

Distribution

US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.

Date initiated

2026-07-02

Date posted

2026-07-28

Location

Irvine, CA

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