Stryker Cross-Screw System

Typical Location

Where this class of equipment is typically deployed - general reference, not this unit's own placement record.

• Operating rooms
• Procedure rooms
• Interventional suites

Documents & Manuals

No documents available for this device yet.

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.

• RECALL

  Seal integrity of the blister pack may be compromised and sterility cannot be assured

• RECALL

  Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in conjunction with the Stryker Navigation System because the settings on the machine were higher than intended. This change led to increased energy directed onto the tip of the Thoracic Pedicle Feeler which caused material degradation where the laser marks exist. There is the potential for the tip of the Thoracic Pedicle Feeler to break.

• RECALL

  Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm.

• RECALL

  Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect.

• RECALL

  Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.

• RECALL

  Stryker Orthopaedics has received a report indicating that the scale of the AxSOS Calibrated Drill Bit 4.3,,X263mm, flat , manufactured by Stryker Osteosynthesis, is incorrect. The incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended.

• RECALL

  Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw.

• RECALL

  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.

• RECALL

  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.

• RECALL

  Two product complaints reported that the Glenoid Reamer Spanner (Lot F3W7017) would not properly connect to the Glenoid Spherical Reamer.

• RECALL

  An incorrect laser mark was noted on specific lots of product, incorrectly implying a stem size of 9, when the product is actually size 8.

• RECALL

  Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices.

• RECALL

  Variations in the outer diameter of the shaft of the External Compression Device and the inner diameter of the Nail Holding Screw may make assembly of these 2 instruments not possible.

• RECALL

  During a sampling inspection, 2 lots of screws did not meet shear and torsion testing specifications.

• RECALL

  The Xia 3 8.5mm Polyaxial screws, lot A91109 were anodized turquoise instead of Fuchsia. The turquoise color is reserved for the 9.5 mm Xia 3 screws.

• RECALL

  The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.

• RECALL

  The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking of the device.

• RECALL

  Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.

• RECALL

  The Reflex Hybrid 4.0 x 14 mm Variable, Self Tapping Bone Screw, Lot NSZ, was determined to have been anodized with the incorrect color for that screw.

• RECALL

  Screws do not have locking threads

• RECALL

  Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws.

• RECALL

  Stryker Orthopaedics became aware that a box labeled as Duracon Total Knee Distal Femoral Locking Screws for 5 mm spacer, may actually contain a 10 mm screw.

• RECALL

  Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.

• RECALL

  The firm has been made aware that one lot of 6.5 Cancellous Bone Screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length.

• RECALL

  Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a potential breach of the sterile barrier.

• RECALL

  The medical device is misbranded in that the package is labeled as Biosteon Interference Screw in fact contains Biosteon Cross Pin. This mislabeling could disrupt surgery preparation resulting in surgery delay.

• RECALL

  The label on the outside of the shipping box has an incorrect description of the screw diameter.