Events

Recall of Device Recall Accolade TMZF Plus Hip Stem

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
    58455
  • Event Risk Class
    Class 2
  • Event Number
    Z-2557-2011
  • Event Initiated Date
    2011-03-01
  • Event Date Posted
    2011-06-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99392
  • 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 ISL
  • Reason
    Accolade tmzf plus hip stems are being recalled due to grit blast media which was observed in the drive hole.
  • Action
    Stryker Orthopaedics sent an Urgent Product Recall letter dated March 1, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fax back the attached Product Recall Acknowledgement Form within 5 days to 201-831-6069. Customers were also instructed to: Contact the hospitals in their territory that have the affected product to arrange return of the product. Return the affected product via and Inter-Org Transfer to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey 07430. Attach the fluorescent orange PRODUCT REMEDIATION sticker to their return, indicating the Product Remediation # RA 2009-459. Mark the outer box with the words "Product Recall." For any questions call (201) 972-2100.

Device

Device Recall Accolade TMZF Plus Hip Stem
  • Model / Serial
    Catalog @ 3020-0537 Accolated TMZF Hip Stem # 5 Lot #31390203 8 units CAtalog #6020-3535 Accolade 132 Size 3.5 Lot #31446602R 0 units  CAtalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Lot #31515703 10 units Catalog # 6021-0335 Accolade Plus TMZF Hipe Stem #3 Lot 31586402 10 units Catalog #3021-0435 Accolade TMZF Hipe STem #4 31597205 1 unit CAtalog # 6021-0435 Accolade Plus TMZF Hipe STem #4 Lot #31597206 4 units Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Lot #31486505 10 units Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 Lot #31850001 1 unit
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Accolade TMZF Plus Hip Stem: || Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 || Catalog #6020-3535 Accolade 132 Size 3.5 || Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 || Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 || Catalog #3021-0435 Accolade TMZF Hip Stem #4 || Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 || Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 || Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 || K994366; k023105; K032300 || Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland || The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.
  • 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