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.
This recall has been terminated (originally issued February 15, 2012).
- Company
- Orthofix, Inc
- Recall Initiated
- February 6, 2012
- Posted
- February 15, 2012
- Terminated
- June 11, 2012
- Recall Number
- Z-1037-2012
- Quantity
- 52
- Firm Location
- Lewisville, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
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.
Root Cause
Device Design
Action Taken
Orthofix mailed recall letters to the distributors on 02/06/2012. Orthofix does not sell or consign these instruments to hospitals.