Events

Recall of RETiLOCK

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Centerpulse Orthopedics, 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
    28512
  • Event Risk Class
    Class 2
  • Event Number
    Z-0809-04
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32028
  • 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
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
  • Reason
    Compalints of acetabular shell disassociating with the bone.
  • Action
    The firm called and issued letters on September 30, 2003 informing physicians of a complaint received. The letter requested that the physicians discontinue use of the device until and investigation could be conducted. On 03/8/2004 the firm issued a letter to Zimmer distributors to return all inventory.

Device

RETiLOCK
  • Model / Serial
    Lot numbers: 1548942, 1548943, 1548944, 1548947, 1548948, 1548949, 1548950, 1553246, 1553248, 1553251, 1553252, 1553254, 1553259, 1553261, 1553262, 1553265, 1553266, 1553268, and 1553269
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Physicians in the following areas: CA, Washington D.C., MD, LA, ID, and WA
  • Product Description
    RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas
  • Manufacturer
    Centerpulse Orthopedics, Inc

Manufacturer

Centerpulse Orthopedics, Inc
  • Manufacturer Address
    Centerpulse Orthopedics, Inc, 9900 Spectrum Dr, Austin TX 78717-4555
  • Source
    USFDA