Device Recall Stryker Orthopaedics Hoffman LRF Telescopic Strut

  • Model / Serial
    K113327 Catalog No:  Telescopic Strut Extra Short Hoffman LRF Length: 4933-0-100 :100-125mm (Black) 4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow) 4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue) 4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red);  Lot Code: 4933-0-100 Telescopic Strut Extra Short Hoffman LRF Length 100-125mm (Black) X28937; Z04197; Z09163; Z09597; Z12135;   4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow) X28961; Z04199; Z09161; Z09769; Z12012;   4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue) X34352; Z04200; Z05068; Z09011; Z09598; Z10872;   4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red); X28963 ;Z04429; Z09471; Z11686
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Hoffman LRF Telescopic Strut Short || Stryker || Stryker Trauma AG || CH-2545 Seizach || Distributed in the USA by || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430. || The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Manufacturer Parent Company (2017)
  • Source
    USFDA