Device Recall Specialist 2

  • Model / Serial
    Product Code 96-6120 Label code / Etch code C3JHN4 H0808 C3JHS4 H0908 C3JHF4 H1008 C4GA54  C4GCC4  C4GBT4  C52F74 H1108 C52GV4 H1208 C52GL4  C67N14  C98CS4 H0109 C98BF4  DE5P34 H0309 DE5RP4  DF4H44  DG9LK4 H0409 DG9L64  DJ5E34  DK3E34 H0509 DK3FE4  EB5FV4 H0210 D95AN4  EB5GH4 H0310 EC9JY4  EF4DJ4  EJ7AP4 H0410 ES2G64 H0510 EJ7A34  ES2HA4 H0610 ES2HY4 H0710 EX5L44  EX5MS4 H0810 E2SD44 H0910 FA4G94 H0211 FD8MP4 H0311 FH8JA4  FH8JX4 H0611 TBACC TBACC TBACZ TBACZ FJ4E74 TBAGG
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide.
  • Product Description
    Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: || Sigma HP Instruments Classic Surgical Technique,0612-89-510 || Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 || Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 || PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique,SP2-007 || Product Usage: || The SP2 IM Rod is used in both primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included in both the SP2 and HP instrument kits.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Manufacturer Parent Company (2017)
  • Source
    USFDA