Events

Recall of Device Recall RECLAIM Revision Hip System; Assembled Implant Inserter Adaptor

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
    70692
  • Event Risk Class
    Class 2
  • Event Number
    Z-1357-2015
  • Event Initiated Date
    2015-02-23
  • Event Date Posted
    2015-03-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134495
  • 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
    This lot of the reclaim assembled implant inserter adaptor instrument may fracture during surgery and there is the potential for plastic pieces to be left in the patient.
  • Action
    The firm issued a voluntary device removal on 02/23/2015 for lot no. SO2018074 of the RECLAIM¿ Assembled Implant Inserter Adaptor. The recall notice informs US Distributors and Medical Professionals about the issue and any actions to take. US Distributors will return affected instruments and notify one Hospital/User Facility with the Hospital Notice and Reconciliation Forms. Reconciliation forms are required for the end-user Hospital/Medical Facility Consignee. Customers may contact Mindy K. Tinsley Director Wordwide Communications Tel: (574) 372-7136 Fax: (574) 372-7717 E-mail: mtinsley@its.jnj.com

Device

Device Recall RECLAIM Revision Hip System; Assembled Implant Inserter Adaptor
  • Model / Serial
    CATALOG NO. : 2975-00-920:  Barcode (GTIN): 10603295156192 Lot No. Distribution SO2018074 (Distributed) SO2018072 (Not Distributed) SO2018073 (Not Distributed) SO2018075 (Not Distributed) SO2018080 (Not Distributed)
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) in CA; Ireland and Israel.
  • Product Description
    RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
  • 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