Class 2 Device Recall OsteoBallast / Ballast

• Date Initiated by Firm: July 02, 2026
• Date Posted: July 28, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2820-2026
• Recall Event ID: 99332
• 510(K)Number: K172130
• Product Classification: Filler, bone void, calcium compound - Product Code MQV
• Product: OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
• Code Information: REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 02-8000-095/10889981149314/181559, 181550
• FEI Number: 3001503333
• Recalling Firm/ Manufacturer: IsoTis OrthoBiologics, Inc.; 2 Goodyear Ste A; Irvine CA 92618-2052
• For Additional Information Contact: 949-5958710
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: 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
• Quantity in Commerce: 98
• Distribution: US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MQV