Z-2820-2026Class II

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

Name: Z-2820-2026 OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF...
Creator: IsoTis OrthoBiologics, Inc.
Published: 2026-07-02
License: https://open.fda.gov/license/

IsoTis OrthoBiologics, Inc. / initiated 2026-07-02 / Open, Classified / root cause: manufacturing process

FDA source

IsoTis OrthoBiologics, Inc. began a recall of OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095 on 2026-07-02. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2820-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-02
Posted: 2026-07-28
Recalling firm: IsoTis OrthoBiologics, Inc.
Product: OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), REF: 02-8000-095
Product code: MQV Filler, Bone Void, Calcium Compound
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.
Root cause tag: manufacturing process
FDA root 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 [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]
Quantity in commerce: 98
Distribution: US Nationwide distribution in the states of AK, NJ, TN, AR, CA, WA, OH.
Product codes and lots: REF/UDI-DI/Lots: 56800095/10889981149352/181559, 181550 02-8000-095/10889981149314/181559, 181550

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2820-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2820-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-05	2026-07-28

Product code MQV

K172130Class IIResorbable Mesh DeviceSeaSpine Orthopedics Corporation / cleared 2017-11-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)