Events

Recall of Device Recall Hinge Coupling Hoffmann LRF

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

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
    79751
  • Event Risk Class
    Class 2
  • Event Number
    Z-1526-2018
  • Event Initiated Date
    2018-03-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163236
  • 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
    Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
  • Reason
    The wrong parts were picked for packaging. the connecting nuts were packed in the packaging labeled with hinge coupling.
  • Action
    Stryker sent an Urgent Product Recall letter dated March 12, 2018, to all affected customers. . Product will be returned to the manufacturer for disposition. Non-responding consignees will be attempted to be contacted a minimum of three times in total. Returned product will be quarantined and returned to the manufacturer. Product will be returned to the manufacturer for disposition. For further questions, please call (201) 831-5272.

Device

Device Recall Hinge Coupling Hoffmann LRF
  • Model / Serial
    Lot # L23745
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA (nationwide) Distribution
  • Product Description
    Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 || Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.
  • Manufacturer
    Stryker GmbH

Manufacturer

Stryker GmbH
  • Manufacturer Address
    Stryker GmbH, Bohnackerweg 1, Selzach Switzerland
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA