Events

Recall of Device Recall DePuy Sigma LCS

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
    73076
  • Event Risk Class
    Class 2
  • Event Number
    Z-0787-2016
  • Event Initiated Date
    2016-01-08
  • Event Date Posted
    2016-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143015
  • 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
    Punch, surgical - Product Code LRY
  • Reason
    Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. this may cause the surgeon to select an insert that is too thin. surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. insert dislocation or spin out, or poor joint mechanics may result, if not noted during surgery. may require revision surgery.
  • Action
    On 1/8/2016, URGENT INFORMATION  RECALL NOTICE for Specific Lots of SIGMA¿ High Performance (HP) MBT Non-Keel Punch Knee Instrument notifications were sent to the affected distributors and Medical Professionals with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc.s Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m.  5 p.m. EDT). For questions about the device recall information provided, please contact Kim Earle, Senior Recall Coordinator, at 574-371-4917 (M-F; 8 a.m.  5 p.m. EDT).

Device

Device Recall DePuy Sigma LCS
  • Model / Serial
    Cat. No. GTIN Lot Description  950502016 10603295227366 ABB92402 SIGMA HP MBT Cemented Punch size 1-1.5  950502017 10603295227373 ABB84491 SIGMA HP MBT Cemented Punch size SZ 2-3  950502018 10603295227380 ABB92358 SIGMA HP MBT Cemented Punch size SZ 4-7  950502020 10603295227403 ABC33125 SIGMA HP MBT Noncemented Punch size 2-3  950502020 10603295227403 ABB81733 SIGMA HP MBT Noncemented Punch size SZ 2-3  950502020 10603295227403 ABB81732 SIGMA HP MBT Noncemented Punch size SZ 2-3  950502021 10603295227410 ABB39952 SIGMA HP MBT Noncemented Punch size SZ 4-7  950502021 10603295227410 ABC33123 SIGMA HP MBT Noncemented Punch size SZ 4-7
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US Nationwide, Armenia, Australia, Austria, Belgium, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, P R China, Portugal, Poland, Russia, Singapore, Slovenia, South Africa, Spain, Sweden, South Korea, Switzerland, Thailand, Turkey, UAE, UK, and Brazil.
  • Product Description
    SIGMA HP MBT Non-Keel Punch Knee Instrument. || Designed to be used as an option in stabilizing the tibial trial during trial reduction.
  • 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