Device Recall SLIFT Extension Shims

  • Model / Serial
    Part Number/Lot Number: 11-50109 43092R; 11-50109 46415; 11-50109 CT12H013; 11 -50109-1 46415-1; 11-50110 43089; 11-50110 43089R; 11-50110 46416; 11-50110-1 46416-1
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT
  • Product Description
    S-LIFT Extension Shims || Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • Manufacturer Parent Company (2017)
  • Source
    USFDA