Class I - Dangerous
Potential for the gold unlock button to separate from the inserter.
Stryker Spine
29 recalls • • Categories: Implants & Prosthetics, Other Medical Devices, Surgical Instruments, Infusion Pumps
Class I - Dangerous
Potential for the gold unlock button to separate from the inserter.
Class I - Dangerous
Potential for the gold unlock button to separate from the inserter.
Class I - Dangerous
Potential for the gold unlock button to separate from the inserter.
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.
Class I - Dangerous
Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.
Class I - Dangerous
The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
Class I - Dangerous
The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
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.
The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.
Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.
There were two potential interference conditions identified with the way the tubing set attaches to the inserter.
Class I - Dangerous
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.
Class I - Dangerous
The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery.
Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.
Class I - Dangerous
Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body.
Surgeons have experienced unthreading of the screwdrivers outer shafts during use.
Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening.
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.
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.
Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu.
Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument.
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.