Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0953-03

Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1

Allen Medical Systems, Inc. / initiated 2003-06-02 / Terminated

The OR Group,Inc. began a recall of Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1 on . The reason FDA records is "Foot Stirrups may detach from mount when user is locking system". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0953-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Allen Medical Systems, Inc.
Product
Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1
Product code
FWZ Operating Room Accessories Table Tray
Reason for recall
Foot Stirrups may detach from mount when user is locking system
FDA root cause
Other
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.
Quantity in commerce
460 units
Distribution
Nationwide Foreign: Australia, Korea, Italy, Hong Kong, Ireland, Czech republic, South Africa,
Product codes and lots
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.