Z-2236-2024 Class II Ongoing

Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T

The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH.

a) 100-22-19, UDI/DI 10885862009302, Lot Numbers: 2051878, 2051881, 2051883, 2051884, 2051897, 2051899, 2051904, 2051906, 2051901, 2583739, 2583740, 2583741, 2583742, 2583743, 2583744, 2583745, 2583746, 2583747, 2583748, 2583749, 2583750, 2583751, 2583752, 2583753, 2583754, 2583755, 2583756, 2583758, 2583763, 2583764, 2583765, 2583766, 2583767, 2583768, 2583771, 2583772, 2583773, 2583774, 2583775, 2583776, 2583777, 2583757, 2583759, 2583760, 2583761, 2583762, 2583769, 2583770, 4413099, 4413105, 4413093, 4413114, 4413100, 4413117, 4413116, 4413112, 6528255, 6528254, 6528269, 6528275, 6528264, 6528259, 6528267, 6528263, 6528257, 6528261, 6528270, 6528256, 2051882, 2051900, 4065533, 4082594, 4356568, 4356569, 4356570, 4356572, 4413101, 4413108, 4413113; b) 100-22-20, UDI/DI 10885862009319, Lot Numbers: 2966253, 2736353, 956428, 956429, 956430, 956431, 956432, 956433, 956434, 956435, 956439, 956440, 956441, 956442, 956443, 956448, 956447, 956426, 956437, 956438, 956444, 956446, 956450, 956427, 956445, 1766644, 1766645, 1766647, 1766648, 1766649, 1766651, 1766652, 1766653, 1766654, 1766662, 1766664, 1766665, 1766669, 1766670, 1766646, 1766650, 1766655, 1766656, 1766657, 1766658, 1766659, 1766660, 1766661, 1766663, 1766666, 1766667, 1766668, 1973677, 1973679, 1973680, 1973681, 1973682, 1973683, 1973684, 1973685, 1973686, 1973688, 1973690, 1973676, 1973678, 1973687, 1973691, 1973693, 1973674, 1973675, 1973689, 1973692, 2074521, 2106219, 2114000, 2114001, 2114002, 2114003, 2114004, 2114005, 2114006, 2114007, 2134272, 2134276, 2134277, 2134278, 2134279, 2134280, 2134273, 2134274, 2134275, 2134281, 2136981, 2136982, 2136983, 2136984, 2136985, 2136986, 2136987, 2136988, 2136989, 2136990, 2136991, 2136992, 2136993, 2136994, 2136995, 2136996, 2209987, 2209988, 2209989, 2209990, 2209991, 2251069, 2251073, 2251074, 2251075, 2251076, 2251077, 2251078, 2251079, 2251080, 2251082, 2251083, 2251084, 2251086, 2251087, 2251088, 2251089, 2251090, 2251091, 2251092, 2251093, 2251066, 2251067, 2251068, 2251070, 2251071, 2251072, 2251081, 2251085, 2254888, 2254889, 2254890, 2254891, 2254892, 2254893, 2254894, 2254895, 2254896, 2254897, 2254898, 2254899, 2254900, 2254901, 2254902, 2254903, 2254904, 2254905, 2254906, 2254907, 2254908, 2254909, 2254910, 2254911, 2254912, 2254913, 2254914, 2351931, 2351932, 2351933, 2351934, 2351935, 2351936, 2351937, 2351938, 2351939, 2351940, 2351941, 2351942, 2351943, 2351944, 2351945, 2351946, 2351947, 2351948, 2351949, 2351950, 2583935, 2583936, 2583937, 2583938, 2583939, 2583940, 2583941, 2583942, 2385507, 2385508, 2385509, 2385510, 2385511, 2385512, 2385513, 2385514, 2385515, 2385516, 2385517, 2385518, 2630904, 2630905, 2630906, 2630907, 2630908, 2630909, 2630910, 2630911, 2630912, 2630913, 2630914, 2630915, 2630916, 2630917, 2630918, 2630919, 2630920, 2736352, 2736355, 2736356, 2736357, 2736358, 2736359, 2736360, 2736361, 2736363, 2736364, 2736365, 2736366, 2736367, 2736369, 2736371, 2736373, 2736374, 2736375, 2736377, 2736378, 2736379, 2736381, 2736382, 2385519, 2962338, 2962339, 2962340, 2962341, 2962342, 2962343, 2962344, 2962345, 2966234, 2966235, 2966236, 2966237, 2966238, 2966239, 2966240, 2966242, 2966244, 2966246, 2966247, 2966248, 2966249, 2966250, 2966251, 2966252, 2966254, 2966255, 2966256, 2966257, 2966241, 2966243, 2966245, 3571556, 3571557, 3571558, 3571559, 3571560, 3571561, 3571562, 3571563, 3571564, 3571565, 3571566, 3571567, 3571568, 3571569, 3571570, 3571571, 3571572, 3571573, 3571574, 3571576, 3571579, 3571580, 3571582, 3571584, 3571585, 3571586, 3571589, 3571590, 3571591, 2736354, 2736362, 2736368, 2736370, 2736372, 2736376, 2736380, 3642893, 3684532, 3642894, 3684533, 3684526, 3571555, 3684523, 3571581, 3684527, 3571583, 3571575, 3571588, 3571587, 3744782, 3684537, 3684538, 3571577, 3571578, 3684524, 3731129, 3731133, 3684531, 3744784, 3744778, 3684525, 3705738, 3642895, 3684535, 3684528, 3684534, 3744779, 3744783, 3744781, 3684530, 3731131, 3731132, 3684529, 3705737, 3684536, 4264663, 3873634, 3744780, 3731130, 3705735, 4479481, 3873636, 4479480, 4264660, 3873635, 3873637, 4487182, 3873638, 4678963, 4678953, 4678967, 3705736, 4264662, 3873640, 4479482, 4479483, 4479485, 4678966, 4678965, 4678951, 4678955, 4678957, 4678947, 4678950, 4678970, 4678964, 4678960, 4678959, 4678958, 4678956, 4487181, 4479479, 4678972, 4678969, 4678954, 4678949, 4678961, 4678952, 4678968, 4678971, 4678962, 4264661, 5853133, 4479484, 4678948, 5853127, 5853140, 5853134, 5853129, 5853132, 5853137, 5853135, 5853142, 5853126, 5853136, 5853130, 5853131, 5853128, 5853139, 5853141; c) 100-22-21, UDI/DI 10885862009326, Lot Numbers: 953626, 953627, 953628, 953629, 953630, 953631, 953632, 953633, 953634, 953635, 953636, 953637, 953638, 953639, 953640, 953641, 953642, 953643, 953644, 953645, 953646, 953647, 953648, 953649, 953650, 956154, 956158, 956160, 956171, 956175; d) 100-22-22, UDI/DI 10885862009333, Lot Numbers: 955631, 955633, 955634, 955635, 955636, 955637, 955638, 955639, 955640, 955641, 955642, 955643, 955644, 955645, 955646, 955647, 955649, 955650, 955651, 955652, 955653, 955654, 955655, 955656, 955657, 955658, 955659, 955660, 955661, 955662, 955663, 955664, 955665, 955666, 955667, 955668, 955669, 955670, 955648, 955671; e) 100-22-23, UDI/DI 10885862009340, Lot Numbers: 956100, 956101, 956104, 956105, 956106, 956107, 956108, 956109, 956110, 956113; f) 100-22-24, UDI/DI 10885862009357, Lot Numbers: 956461, 956462, 956464, 956469, 956470, 956471, 956472, 956473, 956474, 956466; g) 100-22-25, UDI/DI 10885862009364, Lot Numbers: