Events

Recall of Device Recall Allen Medical

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The OR Group,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
    26439
  • Event Risk Class
    Class 2
  • Event Number
    Z-0953-03
  • Event Initiated Date
    2003-06-02
  • Event Date Posted
    2003-06-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27685
  • 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
    Operating Room Accessories Table Tray - Product Code FWZ
  • Reason
    Foot stirrups may detach from mount when user is locking system.
  • Action
    The OR Group notifed the accounts by letter sent Air Borne on 6/6/03 advising users to return the stirrups. The firm will inspect and repair the returned units. The firm expanded the recall to include units manufactured between August 02 and May 03. Recall letters were issued on 9/18/03 via Fed'X with instructions to test and identify the device for correct measurement.

Device

Device Recall Allen Medical
  • Model / Serial
    Serial Numbers-Domestic (424 units): A024096, A025850, A025851, A025852, A025853, A025854, A025855, A025856, A025857, A025858, A025859, A025946, A025947, A025948, A025949, A025950, A025951, A025952, A025953, A025966, A025967, A025968, A025969, A025970, A025971, A025972, A025973, A025974, A025975, A026140, A026141, A026142, A026143, A026144, A026145, A026146, A026147, A026148, A026149, A026370, A026371, A026372, A026373, A026374, A026375, A026376, A026377, A026378, A026379, A026515, A026516, A026517, A026518, A026519, A026520, A026521, A026522, A026523, A026524, A026624, A026625, A026626, A026627, A026628, A026629, A026630, A026631, A026632, A026633, A026694, A026695, A026777, A026778, A026779, A026780, A026781, A026782, A026783, A026784, A026785, A026786, A026787, A026788, A026789, A026790, A026791, A026792, A026793, A026794, A026795, A026796, A026800, A026801, A026934, A026935, A026936, A026937, A026938, A026939, A026940, A026941, A026942, A026943, A026957, A026958, A026959, A026960, A026961, A026962, A026963, A026964, A027061, A027062, A027063, A027064, A027065, A027066, A027067, A027068, A027069, A027070, A027121, A027122, A027123, A027124, A027125, A027126, A027127,  A027128, A027129, A027130, A027290, A027291, A027292, A027293, A027294, A027295, A027296, A027297, A027298, A027299, A027384, A027385, A027386, A027387, A027388, A027389, A027390, A027391, A027392, A027393, A027562, A027563, A027564, A027565, A027566, A027567, A027568, A027569, A027570, A027571, A027572, A027573, A027574, A027575, A027682, A027683, A027684, A027685, A027937, A027938, A027939, A027940, A027941, A027942, A027943, A027944, A027945, A027946, A028052, A028053, A028054, A028055, A028056, A028057, A028058, A028059, A028060, A028061, A028098, A028099, A028100, A028101, A028102, A028103, A028148, A028149, A028162, A028163, A028164, A028165, A028166, A028167, A028168, A028169, A028170, A028171, A028283, A028284, A028285, A028286, A028287, A028288, A028289, A028290, A028448, A028449, A028450, A028451, A028452, A028453, A028663, A028664, A028681, A028682, A028683, A028684, A028685, A028686, A028687, A028688, A028689, A028690, A028899, A028900, A028957, A028958, A028959, A028960, A028961, A028962, A028963, A028964, A028965, A028966, A028967, A028968, A028969, A028970, A028971, A028972, A028973, A028974, A028975, A028976, A029279, A029280, A029281, A029282, A029283, A029284, A029285, A029286, A029287, A029288, A029289, A029290, A029291, A029292, A029293, A029294, A029295, A029296, A029297, A029298, A029576, A029577, A029578, A029579, A029586, A029587, A029588, A029589, A029590, A029591, A029592, A029593, A029594, A029595, A029659, A029660, A029661, A029662, A029663, A029664, A029665, A029666, A029761, A029762, A029763, A029764, A029765, A029766, A029767, A029768, A029769, A029770, A029863, A029864, A029865, A029866, A029867, A029868, A029869, A029870, A029913, A029914, A029915, A029916, A029917, A029918, A029921, A029922, A029923, A029924, A029925, A029926, A029927, A029928, A030171, A030172, A030173, A030174, A030175, A030176, A030177, A030178, A030179, A030180, A030181, A030182, A030183, A030184, A030185, A030186, A030187, A030188, A030189, A030190, A030191, A030192, A030193, A030194, A030425, A030426, A030427, A030428, A030429, A030430, A030431, A030432, A030522, A030523, A030524, A030525, A030526, A030527, A030528, A030529, A030589, A030590, A030591, A030592, A030593, A030594, A030595, A030596, A030597, A030598, A030599, A030600, A030601, A030602, A030754, A030755, A030756, A030757, A030758, A030759, A030760, A030761, A030762, A030763, A030764, A030765, A030766, A030767, A030768, A030769, A030820, A031009, A031010, A031011, A031012, A031013, A031014, A031015, A031016, A031030, A031031, A031032, A031033, A031034, A031035, A031036, A031037, A031078, A031079, A031080, A031081, A031082, A031083, A031084, A031085. Serial Numbers Foreign (36 units):  206359, 206360, 206361, 206362, 209163, 209164, 209165, 209166, 209328, 209329, 209330, 209331, 210572, 210573, 211166, 211167, 212707, 212708, 213337, 213338, 214426, 214427, 215128, 215129, 215938, 215939, 217715, 217716, 218215, 218216, 218221, 218222, 219680, 219681, 222526, 222527.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Australia, Korea, Italy, Hong Kong, Ireland, Czech republic, South Africa,
  • Product Description
    Allen Medical Systems PAL Pro Stirrups || Catalog Number: A-10051-A1
  • Manufacturer
    The OR Group,Inc.

Manufacturer

The OR Group,Inc.
  • Manufacturer Address
    The OR Group,Inc., A Subsidiary of Hill-Rom Inc., One Post Office Square, Acton MA 01720
  • Source
    USFDA