Worldwide Distribution - US Nationwide including (Puerto Rico) and the countries of: Spain, Germany, Australia, Peru, Mexico, Colombia, South Africa, and Israel.
Description du dispositif
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, || Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
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.
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.
Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia and Germany.
Description du dispositif
Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation System, Firebird Spinal Fixation System DDD Instrument Case. || Product is intended for use with the Set Screw Driver (52-1061) and Adjustable Counter Torque Wrench (52-1265) to perform the final tightening of set screws in a spinal implant construct.