Z-1037-2012

Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number...

Name: Z-1037-2012 Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number...
Creator: Orthofix, Inc.
Published: 2012-02-06
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2012-02-06 / Terminated / root cause: design

FDA source

Orthofix, Inc. began a recall of Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating... on 2012-02-06. The reason FDA records is "The 8mm and 10mm Rotating Cutters may fracture during use, specifically during disc space preparation. If an 8mm or 10mm Rotating Cutter does Fracture during use, it may result in a surgical delay estimated to be 30...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1037-2012
Status: Terminated
Initiated: 2012-02-06
Posted: 2012-02-15
Terminated: 2012-06-11
Recalling firm: Orthofix SRL
Product: Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating Cutter), and 89-0030 (FORZA Discectomy Case). Manual surgical instrument comprised of stainless steel and titanium.
Product code: max
Reason for recall: The 8mm and 10mm Rotating Cutters may fracture during use, specifically during disc space preparation. If an 8mm or 10mm Rotating Cutter does Fracture during use, it may result in a surgical delay estimated to be 30 minutes or greater due to preparing the disc space using other instruments or methods and/or retrieving the instrument fragment.
Root cause tag: design
FDA root cause: Device Design
Action: Orthofix mailed recall letters to the distributors on 02/06/2012. Orthofix does not sell or consign these instruments to hospitals.
Quantity in commerce: 52
Distribution: Nationwide and Puerto Rico
Product codes and lots: Catalog Number 89-0452 (8mm Rotating Cutter) - Production Identification (Lot) Numbers 33056-ND25 and 33056-NE19; Catalog Number 89-0454 (10mm Rotating Cutter) - Production Identification (Lot) Numbers 33056-ND26 and 33056-NF02; Catalog Number 89-0030 (FORZA Discectomy Case); UPDATED INFORMATION AS OF 04/12/2012: The firm has revised to amend the affected lot information; lot number 34346-NH30 (PN 89-0545) has been added. At the time of recall initiation 3 units from lot 34346-NH30 were in distribution; all 3 units have since been returned to Orthofix. Recall notice stated all lots are to be returned so all other information remains unchanged.

Product code max

K103111Class IIForza Spacer SystemOrthofix, Inc. / cleared 2011-03-23

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)