Events

Recall of Device Recall Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manual Surgical Instr

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
    60744
  • Event Risk Class
    Class 2
  • Event Number
    Z-0804-2012
  • Event Initiated Date
    2011-08-19
  • Event Date Posted
    2012-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106411
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    Stryker orthopaedics has become ware that there is the potential for the above referenced instruments to fracture in two pieces along the width of the body under the striking plate.
  • Action
    Stryker Orthopaedics sent a Urgent Product Recall update dated August 18, 2011, via FedEx to all affected customers. The letter identified the product(s) the problem and the action needed to be taken by the customer. Our records indicate that you have received the above referenced product(s). It is Stryker's¿ responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. Please assist us in meeting our regulatory obligation by faxing back the attached Product Recall Acknowledgment Form within 5 days to 201-831-6069. Please also contact the hospitals in your territory that have the affected product to arrange return of the product as replacement product becomes available. If you have any further questions please call (201) 831-5158.

Device

Device Recall Custom Straight Accolade Common Name: Handle Classification Name: Orthopedics Manu...
  • Model / Serial
    510 K exempt. All lots I-H08641400 CUSTOM STRAIGHT ACCOLADE  I-H08641400 CUSTOM STRAIGHT ACCOLADE  I-H08641400 CUSTOM STRAIGHT ACCOLADE  I-H08641400 CUSTOM STRAIGHT ACCOLADE  I-H1427HFOO "
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA (nationwide distribution)
  • Product Description
    Brand Name: Custom Straight Accolade¿¿ Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument || Brand Name: Specialty Straight Command¿¿ Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument || Brand Name: Custom Straight Accolade¿¿ || Common Name: Handle || Classification Name: Orthopedics Manual Surgical Instrument || Brand Name: Custom Accolade¿¿ Broach Handle || Common Name: Handle || Classification Name: Orthopedics Manual Surgical Instrument || Brand Name: Custom Accolade¿¿ Broach Handle || Common Name: Handle || Classification Name: Orthopedics Manual Surgical Instrument || Brand Name: Specialty Locking Accolade¿¿ Straight Broach Handle Common Name: Handle Classification Name: Orthopedics Manual Surgical Instrument || Brand Name: Specialty Woodpecker Adapted Accolade¿¿ Broach || Handle || Common Name: Handle || Classification Name: Orthopedics Manual Surgical Instrument || Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430 || The Handles are instruments that attach to the femoral rasps or broaches to prepare the Femoral Canal in total hip replacement procedures. The rasps have a geometry similar to the final size and shape of the implant. The straight design allows the rasp handle to be used in standard or minimally invasive approaches because it minimizes the contact with adjacent soft tissue. The Handle is impacted with a slotted mallet on the top and on the bottom portions of the striking plate, to achieve rasp insertion and extraction respectively. The handles share the same geometry in the region that is of interest in this matter.
  • 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