Z-2236-2024Class II

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

Name: Z-2236-2024 Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b)...
Creator: Exactech, Inc.
Published: 2024-04-26
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2024-04-26 / Open, Classified / root cause: packaging

FDA source

Exactech, Inc. began a recall of 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... on 2024-04-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2236-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-26
Posted: 2024-06-28
Recalling firm: Exactech, Inc.
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
Product code: KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Reason for recall: 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 tag: packaging
FDA root cause: Other
Action: 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 .
Quantity in commerce: 589 units
Distribution: Worldwide - US distribution in Puerto Rico and the countries of Great Britain, Japan.
Product codes and lots: 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:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2236-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2236-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-06-28

Product code KWY

K013211Class IIModification to: Acumatch L-Series Bipolar EndoprosthesisExactech, Inc. / cleared 2001-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)