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OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095 recallZ-2820-2026 · IsoTis OrthoBiologics, Inc. · initiated Jul 2, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from IsoTis OrthoBiologics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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 [email protected]. For questions regarding this recall, including product return, replacement, or credit, please contact Audrey Mudderman, Senior Post Market Surveillance Specialist, at [email protected]

Recall details

Recall number
Z-2820-2026
Status
Open, Classified
Initiated by the company
Jul 2, 2026
Posted by the FDA
Jul 28, 2026
Recalling firm
IsoTis OrthoBiologics, Inc.
Quantity
98
Product code
MQV
FDA submissions
K172130
Distribution
US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.

Product description

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

Code information (models, lots, serial numbers)

REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 02-8000-095/10889981149314/181559, 181550

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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