Stryker Spine Recalls

Hazard: Potential for the gold unlock button to separate from the inserter.

Hazard: Potential for the gold unlock button to separate from the inserter.

Hazard: Potential for the gold unlock button to separate from the inserter.

Hazard: Potential for the gold unlock button to separate from the inserter.

Hazard: Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.

Hazard: Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.

Hazard: The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.

Hazard: The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.

Hazard: Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found non-conformances with the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger that could lead to device failure during a procedure.

Hazard: The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.

Hazard: There were two potential interference conditions identified with the way the tubing set attaches to the inserter.

Hazard: Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.

Hazard: Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because it does not have an associated 510(k) submisstion and subsequent clearance, which is required as this is a class 2 device.

Hazard: The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.

Hazard: Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.

Hazard: Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.

Hazard: Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.

Hazard: Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.

Hazard: Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.

Hazard: Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.

Hazard: Surgeons have experienced unthreading of the screwdrivers outer shafts during use.

Hazard: Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.

Hazard: Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.

Hazard: Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.

Hazard: Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm.

Hazard: The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile" and require sterilization before use in surgery.

Hazard: Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument.

Hazard: Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu.

Hazard: Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS Navigator trial failing at the junction of the trial head.