Events

Recall of Device Recall SIGMA HP Fixed Bearing Tibial Tray Impactor

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
    60320
  • Event Risk Class
    Class 2
  • Event Number
    Z-0930-2012
  • Event Initiated Date
    2011-12-13
  • Event Date Posted
    2012-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105029
  • 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
    Impactor - Product Code HWA
  • Reason
    All lots of depuy, sigma hp fixed bearing tibial tray impactors are being recalled because the impactor can become intentionally locked on the tibial tray implant during surgery.
  • Action
    The firm, DePuy, sent an "URGENT INFORMATION - MEDICAL DEVICE RECALL NOTICE" email dated December 13, 2011 to its customers. The email notice described the product, problem and actions to be taken. The customers were instructed to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN; follow the instructions provided and complete and return the Fax Back Response card via fax to: 574-372-7567 or email: kseppa@its.jnj.com by December 23, 2011. For questions about recall information provided, please contact Manager of Customer Quality at 574-372-7333 (M-F; 8 am - 5 pm EST.) For product-related questions from Sales force, please contact Group Product Director at 574-372-7538 (M-F; 8 am - 5 pm EST.) or your local DePuy Orthopaedics sales representative. For clinical-related questions from surgeons, please contact DePuy's Scientific Information Office at 1-888-554-2482 (M-F; 8 am - 5 pm EST.)

Device

Device Recall SIGMA HP Fixed Bearing Tibial Tray Impactor
  • Model / Serial
    Catalog number 9505-01-306 (all lots):071089, 071812, 071989, 072017, 072219, 072220, 072221, 072222, 080026, 080027, 080028, 080029, 080319, 080336, 080337, 080338, 080403, 080404, 080405, 080406, 080407, 080632, 080633, 080634, 080635, 080841, 080842, 080843, 080844, 080845, 080846, 080847, 080848, 080849, 081138, 082151, 082152, 082153, 082175, 082176, 082177, 082178, 082260, 082261, 082262, 082263, 082264, 082265, 082266, 082267, 082268, 082269, 083106, 083107, 083108, 083109, 083110, 083111, 083400, 083401, 083402, 083403, 083404, 083405, 083406, 083407, 083408, 083409, 083495, 090237, 090238, 090239, 090240, 090241, 090242, 090933, 090934, 090935, 090936, 090937, 090938, 090939, 090940, 090941, 090942, 094951, 094952, 100059, 100060, 100172, 100173, 100174, 100455, 100456, 100457, 100458, 100459, 100460, 100469, 100470, 100787, 102110, 102111, 102616, 102617, 102618, 102619, 102620, 102621, 102622, 102623, 102624, 104779, 104780, 105278, 105279, 110046, 110047, 110343, 110344, 110345, 110725, 110726, 110727, 110728, 110729, 111011, 111012, 111013, 112537, 112538, and 112539
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Canada, Ireland and South Africa.
  • Product Description
    The SIGMA¿ HP Fixed Bearing Tibial Tray Impactor is part of a set of tools designed specifically for the installation of the PFC SIGMA¿ Knee. SIGMA HP Fixed Bearing Tibial Tray Impactors Packaged in poly bag with optional protection from sharp or fragile points, distributed by DePuy International Leeds, UK. Instruments are supplied non-sterile and do not have specified expiration date or shelf life. || Usage: The Tibial Tray (with protective cover) and instrument are assembled outside of the patient in theatre; the tray is introduced and impacted into the cement containing tibia using the impactor. Once the tray is fully seated in the cement containing tibia, the instrument is intended to be removed.
  • 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