Events

Recall of Device Recall Specialist 2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DePuy Orthopaedics, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63973
  • Event Risk Class
    Class 2
  • Event Number
    Z-0971-2013
  • Event Initiated Date
    2013-02-05
  • Event Date Posted
    2013-03-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116519
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    Potential for the im rod to break, leaving fragments in the patient. surgical techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure.
  • Action
    DePuy Orthopaedics sent an Urgent Medical Device Correction Notice letter dated February 5, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete and return the FAX back form to FAX 574-371-4939 or email kseppa@its.jnj.com Questions about device correction information call Post Market Surveillance, 574-372-7333, Sales force questions call Product Specialist, 574-372-7303 and Surgeon questions DePuy's Scientific Information Office at 1-888-554-2482.

Device

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
    Orthopedic Devices
  • 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
    DePuy Orthopaedics, Inc.

Manufacturer

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