Events

Recall of Device Recall USS Small Stature

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes USA HQ, Inc..

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
    65563
  • Event Risk Class
    Class 2
  • Event Number
    Z-1935-2013
  • Event Initiated Date
    2013-06-05
  • Event Date Posted
    2013-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119580
  • 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
    Orthosis, spinal pedicle fixation - Product Code MNI
  • Reason
    Depuy synthes has issued a medical device correction notice for the 5.0mm stainless steel rods. this product was produced using a finishing process not identified as part of the manufacturing specification. no adverse event reports associated with the use of this product were received, and an extensive engineering and medical safety review concluded that the product poses no incremental risk to t.
  • Action
    On June 5, 2013, De Puy Synthes notified by letter the direct acc acccounts which were identified to have received 5.0mm stainless steel rods and requested return of the product by calling 1-800-479-6329 to obtain a return authorization number. Completion of the verification section of the letter, including negative responses was also requested.

Device

Device Recall USS Small Stature
  • Model / Serial
    Part Numbers: 298.269 298.270 298.271 298.272 298.273 298.274 298.275 298.276 298.277 298.278  with lot numbers:  4729951; 4841209; 4923651; 4923652; 4987688; 4987750; 5350635; 2002330; 3000595 4729952; 4841210; 4923653; 4923654; 4987683; 4856248; 4987755; 5153848; 5153853; 1602596; 1880489 4729953; 4841211; 4923666; 4923667; 4987778; 4856275; 4987761; 5159826; 5157329; 3016224  4729954; 4841212; 4919162; 4923669; 4987779; 4856250; 4987766; 5153796; 3093619 4729956; 4923674; 4987825; 4987780; 5066363 4729958; 4923615; 4987826; 4987781; 5066364 4729959; 4841213; 4923655; 4936270; 4987684; 4987771; 5153849; 5153854 4729960; 4835367; 4923656; 4923657; 4984982; 4856246; 4987772; 5159827; 5157330  4729961; 4835368; 4923658; 4923659; 4987685; 4856249; 4987773; 1602617; 3080451 4729962; 4835378; 4919165; 4923660; 4987686; 4856252; 4987776; 5153851
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    5.0mm Unit Rod 270mm || 5.0mm Unit Rod 290mm || 5.0mm Unit Rod 310mm || 5.0mm Unit Rod 330mm || 5.0mm Unit Rod 350mm || 5.0mm Unit Rod 370mm || 5.0mm Unit Rod 390mm || 5.0mm Unit Rod 410mm || 5.0mm Unit Rod 430mm || 5.0mm Unit Rod 450mm || pedicle screw spinal system; || Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

Synthes USA HQ, Inc.
  • Manufacturer Address
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA