Events

Recall of Device Recall RSP Impaction Fixture

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Encore Medical, Lp.

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
    76456
  • Event Risk Class
    Class 2
  • Event Number
    Z-1413-2017
  • Event Initiated Date
    2017-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153337
  • 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
    During the turon assembly, the impaction forces caused the polymer, black acetal copolymer from the impaction fixture to wear off on the lateral surface of the humeral stem titanium plasma spray coating.
  • Action
    There are two field safety notices, one for Consignees who have surgeons that use the impaction fixtures (Verson 1) and one for Consignees who had previously indicated their surgeons do NOT use the impaction fixtures (Verson 2). The two recall notification letters were sent out on 2/9/17.

Device

Device Recall RSP Impaction Fixture
  • Model / Serial
    109931L01, 109931L02, 115670L15, 115670L16, 128092L08, 128092L09, 137917L16, 167829L06, 52258L01, 52258L01A, 67428L01, 76386L01, 76386L02, 81722L01, 81722L02
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany
  • Product Description
    RSP Impaction Fixture
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758-5445
  • Manufacturer Parent Company (2017)
    The Blackstone Group LP
  • Source
    USFDA