—#207612

Product

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

FDA product code: KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K013211
Affected lot / code info: 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:

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.

Root cause (FDA determination)

Other

Action the firm took

Exactech issued an UREGNT VOLUNTARY MEDICAL DEVICE RECALL notice to its sales representatives on 04/26/2024 via email. The notice explained the issue, clinical impact (risk), and requested the following: Actions to be Taken: " Review this notification thoroughly. " Immediately discontinue use and quarantine any affected product. " Distribute this Recall Letter to all the surgeons who have implanted the affected devices. " Send all affected product back to Exactech as outlined in the attached Recall Confirmation Form .

Recalling firm

Firm: Exactech, Inc.
Address: 2320 Nw 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: Worldwide - US distribution in Puerto Rico and the countries of Great Britain, Japan.

Timeline

Recall initiated: 2024-04-26
Posted by FDA: 2024-06-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207612. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.