Reported Jul 10, 2024 · Ongoing

Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20,…

Exactech, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630

Is this the product you have?

7 of 7 products

Products covered by this recall
#	Product as published
1	100-22-19, SZ. L
2	100-22-20, SZ. M
3	100-22-21, SZ. N
4	100-22-22, SZ. P
5	100-22-23, SZ. R
6	100-22-24, SZ. S
7	100-22-25, SZ. T

Lot codes and dates: 7 of 7 products
Products covered by this recall
# Barcodes Product as published
1 10885862009302 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
2 10885862009319 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
3 10885862009326 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
4 10885862009333 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
5 10885862009340 100-22-23, UDI/DI 10885862009340, Lot Numbers: 956100, 956101, 956104, 956105, 956106, 956107, 956108, 956109, 956110, 956113
6 10885862009357 100-22-24, UDI/DI 10885862009357, Lot Numbers: 956461, 956462, 956464, 956469, 956470, 956471, 956472, 956473, 956474, 956466
7 10885862009364 100-22-25, UDI/DI 10885862009364, Lot Numbers
Amount recalled: 589 units

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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By hazard

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58 in total.

Where it was distributed

Puerto Rico recalls

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`10885862009302`	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
2	`10885862009319`	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
3	`10885862009326`	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
4	`10885862009333`	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
5	`10885862009340`	100-22-23, UDI/DI 10885862009340, Lot Numbers: 956100, 956101, 956104, 956105, 956106, 956107, 956108, 956109, 956110, 956113
6	`10885862009357`	100-22-24, UDI/DI 10885862009357, Lot Numbers: 956461, 956462, 956464, 956469, 956470, 956471, 956472, 956473, 956474, 956466
7	`10885862009364`	100-22-25, UDI/DI 10885862009364, Lot Numbers