Events

Recall of PCA 10 Degree Hooded Acetabular Insert ID 22mm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Howmedica Osteonics Corp..

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
    72506
  • Event Risk Class
    Class 2
  • Event Number
    Z-0281-2016
  • Event Initiated Date
    2015-10-15
  • Event Date Posted
    2015-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141303
  • 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/polymer, cemented - Product Code JDI
  • Reason
    Six (6) pca 10 degree hooded acetabular insert-duration 22 mm (id) have been distributed in the us, although the 22 mm size was inadvertently omitted from 510(k) #k963612.
  • Action
    Stryker sent an Urgent Medical Device Recall Notification letter dated October 15, 2015, to all affected customers. The notification instructed consignees on how to identify affected product; the related issue with the affected product; potential hazards; risk mitigations; and actions needed to be taken. Customers were instructed to quarantine the affected product. Consignees were asked to complete and return the attached Product Recall Acknowledgement Form within 5 days and either email (strykerortho7984@stericycle.com or Fax (1-866-672-0627 ) the response form back. Customers with questions were instructed to call 201.831.5272.

Device

PCA 10 Degree Hooded Acetabular Insert ID 22mm
  • Model / Serial
    Catalog Number:Lot Number; 6299-8-403:23182601; 6299-8-469:19123701; 6299-8-525:29115601; 6299-8-525:22727301; 6299-8-581:17772401; 6299-8-581:28432001.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distribution to Virginia only.
  • Product Description
    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, || Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA