Events

Recall of Omnifit M/S PSL Porous Coated Acetabular Shell

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
    56448
  • Event Risk Class
    Class 2
  • Event Number
    Z-1049-2011
  • Event Initiated Date
    2010-08-02
  • Event Date Posted
    2011-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93700
  • 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, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
  • Reason
    Stryker orthopaedics determined that specific lots of the omnifit acetabular shells may have a screw hole wall thickness that falls above the design specification.
  • Action
    The firm, Stryker Orthopaedics, sent an "URGENT PRODUCT RECALL" letter dated August 2, 2010, via Federal Express to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory to identify the affected product; retrieve all affected product and return it their branch or agency warehouse for reconciliation; reconcile all product(s) on the attached Product Recall Acknowledgement Form and fax to (201) 831-6069, and return the affected product via Inter-Org Transfer and ship to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100.

Device

Omnifit M/S PSL Porous Coated Acetabular Shell
  • Model / Serial
    Catalog number 2017-0046, Lot7E3029, 7K3015, 7K3015A, 8K3048, *m3038, 8M3038A, MHMJW8.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including states of: AL, AR, CA, FL, IN, ME, MI, MS, NC, NJ, OK, OR, WA , and WI; and countries including: China, Hong Kong and Korea.
  • Product Description
    Omnifit M/S PSL Porous Coated Acetabular Shell 46MM; || Stryker Orthopaedics, || Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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