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Alvarado Knee Positioner Recall & Alternatives

June 18, 2019

On 4/26/2019 Zimmer Biomet issued a Class II Recall for inadequate cleaning for all Alvarado Knee Holder Base Plate Assembly and Foot Piece as well as all Alvarado II Base Plate and Foot Piece. 

Rest assured, SchureMed has the best engineered and manufactured TKR product on the market. Not only is the TKR Positioner for Total Knee Replacement superior in quality compared to the Alvarado Knee Positioner, but it is also cost-effective and easy to maintain. The SchureMed TKR Positioner is one of our top selling products safely assisting surgeons worldwide with total knee replacement procedures. Our product design includes welded boot edges that are completely closed and cannot become penetrated or contaminated with fluids like the recalled Alvarado Knee Holder. The TKR Positioner also has a CE Marking indicating that it conforms with health safety and environmental protection standards for products sold within the European Economic Area.

About the TKR Positioner
The TKR TRACK BALL SYSTEM 24” or 30” is a surgical accessory that allows the surgeon to position the operative leg during total knee replacement surgery. The intended use is to allow the surgeon to position the operative leg in multiple positions (extension, flexion, tilt and rotation) during total knee replacement surgery. Our TKR Positioner is constructed out of premium materials, aluminum and stainless steel—surpassing the quality of the recalled Alvarado Knee Positioner. The 24" model is 24"L x 8"W and our 30" model is 30"L x 8"W. TKR Overview of Components is available in downloadable format for your convenience.

Quick facts:

  • This product is not made with (NRL) Natural Rubber Latex
  • This device supports a 500 lb proportional patient load (6'4" tall patient per 99% human body model)
  • Product warranty covers the product from manufacturing defects for a period of 2 years.
  • If damaged in shipping, please call Customer Service at (888) 724-8763 or 781 982-7000 to obtain a Return Material Authorization (RMA) number. For product warranty issues also contact Customer Service
  • This product is maintenance free, check the condition of the product each time before using it
  • Life of device is 5 years under normal use
  • Storage of device shall be between –4 °F to +86 °F
  • All components must be cleaned before and after use.
  • All components need to be Autoclaved or flash sterilized

How to Use the TKR Positioner
Using the TKR Positioner for total knee replacement surgeries rather than an Alvarado Knee Holder is simple when following the instructions below.

Quick Facts

  • Drape the surgical table
  • Attach the rail clamp to the rail (a). Then flip the locking lever (b) right or left to secure. (DO NOT ATTACH OVER THE NOTCHES WITHIN THE SIDE RAIL).
  • Slide the track system crossbar (c) into the rail clamp, approximately 2” from patient’s heel. Securely tighten the track system crossbar by turning the rail clamp star knob to the right (d).
  • Slide the base plate (e) into the cross support bar (f) making sure its flush. Tighten the two star knobs (g) by turning to the right.
  • Slide the adjustable slide block (h) on to the track system. WARNING! Only adjust the adjustable slide block lever when it is on the track.
  • Place the adjustable boot ball (i) into the track system’s adjustable slide block.
  • Line the boot with our sterile disposable boot liner #800-0146 (sold separately as a case of 12)
  • Prep and position patient, turn the slide block locking handle (j) right to lock into desired position

TKR for Total Knee Replacement TKR for Total Knee Replacement - Leg Straight TKR for Total Knee Replacement - Leg Flexed

How to Clean the TKR Positioner
Keeping the TKR Positioner clean is imperative for carrying out surgical procedures effectively. Cleaning the TKR Positioner thoroughly before using (before sterilization) and after each use is key to the success of this product but requires little to no maintenance, unlike the Alvarado Knee Positioner which has since been recalled for withholding blood and contaminants from previous surgeries.

Recommended cleaning products: (All solutions should be used in accordance with manufacturer’s instructions)

  • Enzymatic neutral pH detergent solution (enzymatic cleaners are compatible with metal devices/instruments and are preferred)
  • Non-enzyme, hydrogen peroxide-based solution
  • Coverage Plus NPD One Step Cleaner, Disinfectant & Deodorizer Concentrate

Disassemble TKR Positioner into separate parts for cleaning:

  • Boot Ball
  • Mounting Plate with Clamp
  • Base Plate with Track
  • Slide Block with Handle

Hand Cleaning:

  • Scrub each piece with a soft, plastic scrub brush and a recommended cleaning solution (see above)
  • Rinse all parts thoroughly to remove any chemical residue
  • Wipe each part completely dry with a clean, lint-free cloth

Washer Cleaning

  • Put through washer / decontaminator according to manufacturer’s instruction (select cycle that does not included lubrication)
  • Prepare for sterilization (device must be cleaned before sterilization)
  • Follow corresponding steam sterilization instructions on the TKR Cleaning Instructions download

Our Instructions for Use & Cleaning Instructions explain the proper use & sanitizing methods for the TKR in a downloadable format.