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.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
