Events

Recall of VHS

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

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
    36377
  • Event Risk Class
    Class 3
  • Event Number
    Z-0180-2007
  • Event Initiated Date
    2006-09-06
  • Event Date Posted
    2006-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48514
  • 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
    hip screw system - Product Code KTT
  • Reason
    Vhs plate and lag screw components did not assemble correctly intraoperatively.
  • Action
    Recall notification was sent out by US mail on 9/6/2006 indicating the lot number(s) of product received.

Device

VHS
  • Model / Serial
    200511 Intermediate VHS Lag Screw 35MM. Lot #s 089397, 224149, 227018,228282, 276052,284944,299271,321772,326236, 572150,576380. 200512 Intermediate VHS Lag Screw 40 MM, Lot #s115120, 172137,257775,271524,297135,299272,572160,576400. 200513 Intermediate VHS Lag Screw 45 MM, Lot #s 089398,197199,210829,243847,284087,297136,307909, 309419, 749310. 200514 Intermediate VHS Lag Screw 50 MM, Lot #s 115130,174095,224464,276169,276053,284088,299273, 326237, 749340. 200515 Intermediate VHS Lag Screw 55MM, Lot #s 089399,178703,224167,275771, 297137,321775,326238,333721,572180, 576410. 200516 Intermediate VHS Lag Screw 60 MM, Lot #s 089400,227860,275775,277702,287521,299274,301001, 344610, 749350. 200517 Intermediate VHS Lag Screw 65 MM, Lot #s 089401,224293,275778,284945,297138,299275,321776, 749370. 200518 Intermediate VHS Lag Screw 70 MM, Lot #s 089402,243848,275780,287522,297139,304127,749380. 200519 Intermediate VHS Lag Screw 75 MM, Lot #s 089403,267170,267172,299276,321777,352316,353922, 366390,749390,. 200520 Intermediate VHS Lag Screw 80 MM, Lot #s 104564,  168448, 285930,321778, 329174..299277,299278,302214,321784,366400, 747410. 200521 Intermediate VHS Lag Screw 85 MM, Lot #s 089404, 267171, 275783,299277,299278,302214,321784,366400, 747410. 200522 Intermediate VHS Lag Screw 90 MM, Lot #s 168449,  284947,321782,329175,357520. 200523 Intermediate VHS Lag Screw 95MM, Lot #s 104567,168294,217920,344219,345861,347823.361016, 749420. 200524 Intermediate VHS Lag Screw 100MM, Lot #s 104570, 168450,181749,302216,312049,321786,342630,749430.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    VHS Pediatric Hip Screw System || Ped VHS, Lag Screw || Ref # 200516 || Stainless Steel, Rx only
  • Manufacturer
    EBI, L.P.

Manufacturer

EBI, L.P.
  • Manufacturer Address
    EBI, L.P., 100 Interpace Pkwy, Parsippany NJ 07054-1149
  • Source
    USFDA