Device Recall Malleable C Retractor

  • Model / Serial
    Part Number 397.232, Lot Numbers  1698700 4688882 4868698 5129449 5345722 6009689 6235842 6407718 1702300 4688883 4916060 5129450 5356127 6021041 6241331 6407719 1715800 4772507 4916061 5129453 5382066 6023019 6258401 6446480 175220 4772508 4916062 5247085 5422622 6023020 6258402 6446481 1685602 4814278 4991953 5247087 5664372 6040195 6300954 6452871 1695100 4814280 4991962 5263641 5664373 6040196 6321761 6452872 1695101 4814281 4992455 5267067 5685461 6056610 6345256 6623687 1706600 4868678 5032047 5267068 5820702 6097962 6345257 6633304 1776300 4868685 5080386 5287150 5839165 6181398 6355110  1798900 4868691 5080387 5287152 5855648 6212655 6407717
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and internationally to Canada.
  • Product Description
    Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
  • Source
    USFDA