Stryker Eye Surgery

Technical Specs

Height

23.25 to 36 inches

Length

90 in

Patient Weight Capacity

500 lbs

Width

31.5 in with siderails up

Typical Location

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

• Ambulance / transport vehicles
• Emergency Department
• Inter-facility transport teams

Documents & Manuals

• Stryker Eye Surgery Stretcher specs sheetDocument · External

Safety & Recalls

Synced live from the FDA openFDA API.

• RECALL

  Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.

• RECALL

  There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).

• RECALL

  Product was distributed without receiving regulatory clearance.

• RECALL

  Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.

• RECALL

  Stryker C2 NerveMonitor's design and instructions may not optimally address usability issues related to the functionality of the device, which may result in use errors potentially causing or contributing to nerve injury.

• RECALL

  Product shipped proximate to or past the expiration date listed on the product label.

• RECALL

  Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

• RECALL

  Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument.

• RECALL

  Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potentially resulting in disassociation from the instrument.

• RECALL

  Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa.

• RECALL

  It was reported that packaging was not properly sealed.

• RECALL

  Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST).

• RECALL

  Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm because there is a potential that the weld seam between the main stud and the two flaps on the Articulated Arm was not welded in the correct location, which may result in a potential failure of the arm joint.

• RECALL

  Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.

• RECALL

  Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.

• RECALL

  There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

• RECALL

  Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.

• RECALL

  The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100

• RECALL

  The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.

• RECALL

  Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.

• RECALL

  Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater than 250 LBS.

• 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

  Recalled device was packaged with the incorrect angled blade. The labeling indicates a 12 degree angle but the product has a 40 degree angle.

• RECALL

  When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlation results or incorrectly shown orientation of every second image series during navigation.

• RECALL

  Stryker Orthopaedics became aware that there is the potential for the Scorpio T72 tibial Insert Trials to be oversized by a maximum of .024" (0.6mm).

• RECALL

  Users may experience issues with the functionality of the SwitchPoint Infinity 2 and SwitchPoint Element that may be exhibited as a "Page Not Found" error message, missing drop down options, or a frozen touch panel.

• RECALL

  The fowler of the bed is raised by a crank. The crank cosnsists of a steel screw that moves through a brass nut. Over time the screw can wear the threads on the brass nut. The screw and the nut can become misaligned, causing a loud squealing noise when the screw comes in contact with the drive tube. In addition the fowler can become inopperable over time with excessive wear of the brass nut.

• RECALL

  Potential for health care provider/hospital staff member to sustain injury to fingers or hands when removing/handling the headrest component of the VERTIER Surgical Table.

• RECALL

  The Inner Shaft does not extend far enough from the tip of the Revision Screwdriver to fully engage the bone screw.

• RECALL

  The coupler on this device was manufactured without set-screws that are used to hold and center the rear assembly and the endobody. The coupler is part of the camera system and affects the ability to focus.

• RECALL

  The t-bar of the Radius Rod Persuader devices froze due to a loosening screw causing the device to fail.

• RECALL

  An incorrect pin may have been used during assembly and therefore the device may give way during use.