Events

Recall of Device Recall Restoration

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

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
    28052
  • Event Risk Class
    Class 2
  • Event Number
    Z-0571-04
  • Event Initiated Date
    2003-12-30
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31115
  • 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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
  • Reason
    Restoration t3 revision hip system distal stem has demonstrated fractures.
  • Action
    Product recall letters and accountability forms were sent via FedEx on 12/30/2003 with return receipt.

Device

Device Recall Restoration
  • Model / Serial
    All Lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The following direct accounts received the device: Branches/Agencies: 46; Hospitals: 526; Government Hospitals: 23; International Distributors: 10; Latin America: 3; Canada: 1; and Asia Pacific: 3.
  • Product Description
    Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. || 6260-3-014 T3 MOD REV DIST STM 14MMX225MM; || 6260-3-015 T3 MOD REV DIST STM 15MMX225MM; || 6260-3-016 T3 MOD REV DIST STM 16MMX225MM; || 6260-3-017 T3 MOD REV DIST STM 17MMX225MM; || 6260-3-018 T3 MOD REV DIST STM 18MMX225MM; || 6260-3-019 T3 MOD REV DIST STM 19MMX225MM; || 6260-3-020 T3 MOD REV DIST STM 20MMX225MM; || 6260-3-022 T3 MOD REV DIST STM 22MMX225MM; || 6230-3-024 T3 MOD REV DIST STM 24MMX225MM; || 6260-3-114 T3 MOD REV DIST STM 14MMX265MM; || 6260-3-115 T3 MOD REV DIST STM 15MMX265MM; || 6260-3-116 T3 MOD REV DIST STM 16MMX265MM; || 6260-3-117 T3 MOD REV DIST STM 17MMX265MM; || 6260-3-118 T3 MOD REV DIST STM 18MMX265MM; || 6260-3-119 T3 MOD REV DIST STM 19MMX265MM; || 6260-3-120 T3 MOD REV DIST STM 20MMX265MM; || 6260-3-122 T3 MOD REV DIST STM 22MMX265MM; || 6260-3-124 T3 MOD REV DIST STM 24MMX265MM; || 6260-3-214 KINKED T3 DIST STM 14MMX265MM; || 6260-3-215 KINKED T3 DIST STM 15MMX265MM; || 6260-3-216 KINKED T3 DIST STM 16MMX265MM; || 6260-3-217 KINKED T3 DIST STM 17MMX265MM; || 6260-3-218 KINKED T3 DIST STM 18MMX265MM; || 6260-3-219 KINKED T3 DIST STM 19MMX265MM; || 6260-3-220 KINKED T3 DIST STM 20MMX265MM; || 6260-3-222 KINKED T3 DIST STM 22MMX265MM; || 6260-3-224 KINKED T3 DIST STM 24MMX265MM; || 6260-3-314 KINKED T3 DIST STM 14MMX305MM; || 6260-3-315 KINKED T3 DIST STM 15MMX305MM; || 6260-3-316 KINKED T3 DIST STM 16MMX305MM; || 6260-3-317 KINKED T3 DIST STM 17MMX305MM; || 6260-3-318 KINKED T3 DIST STM 18MMX305MM; || 6260-3-319 KINKED T3 DIST STM 19MMX305MM; || 6260-3-320 KINKED T3 DIST STM 20MMX305MM; || 6260-3-322 KINKED T3 DIST STM 22MMX305MM; || 6260-3-324 KINKED T3 DIST STM 24MMX305MM; || LR3ST RESTORATION REV HIP SYS SURGICAL TECHNIQUE; || 6262-7-000-0 RESTORATION REV HIP SYS TEMPLATE SET FOR STRAIGHT STEMS ONLY; || LTEM71 1-9 RESTORATION REV HIP SYS 265MM BOWED STEM TEMPLATES; || LTEM72 1-9 RESTORATION REV HIP SYS 305MM BOWED STEM TEMPLATES.
  • Manufacturer
    Stryker Howmedica Osteonics

Manufacturer

Stryker Howmedica Osteonics
  • Manufacturer Address
    Stryker Howmedica Osteonics, 300 Commerce Ct, Mahwah NJ 07430-2104
  • Source
    USFDA