FDAFDA · Food and drugs·Recall number Z-1728-2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE LINER 28MM SZ H, REF 130-28-28 e. ACUMATCH GXL 0 DEGREE LINER 28MM SZ J, REF 130-28-29 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ G, REF 130-32-27 g. ACUMATCH GXL 0 DEGREE LINER 32MM SZ H, REF 130-32-28 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ J, REF 130-32-29 g. ACUMATCH GXL 0 DEGREE LINER 36MM SZ H, REF 130-36-28 h. ACUMATCH GXL 0 DEGREE LINER 36MM SZ J, REF 130-36-29 i. ACUMATCH GXL 0 DEGREE LINER 36MM SZ K, REF 130-36-30 j. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ E, REF 138-28-25 k. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ F, REF 138-28-26 l. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ G, REF 138-28-27 m. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ H, REF 138-28-28 n. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ J, REF 138-28-29 o. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H, REF 138-36-28 p. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ J, REF 138-36-29 q. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ K, REF 138-36-30 r. ACUMATCH GXL 15 DEG +5 LAT LINER SZG 38MM, REF 138-36-27 s. ACUMATCH GXL 15DEG LINER 28MM SZ D, REF 132-28-24 t. ACUMATCH GXL 15DEG LINER 28MM SZ E, REF 132-28-25 u. ACUMATCH GXL 15DEG LINER 28MM SZ F, REF 132-28-26 v. ACUMATCH GXL 15DEG LINER 28MM SZ G, REF 132-28-27 w. ACUMATCH GXL 15DEG LINER 28MM SZ H, REF 132-28-28 x. ACUMATCH GXL 15DEG LINER 28MM SZ J, REF 132-28-29 y. ACUMATCH GXL 15DEG LINER 28MM SZ K, REF 132-28-30 z. ACUMATCH GXL 15DEG LINER 32MM SZ G, REF 132-32-27 aa. ACUMATCH GXL 15DEG LINER 32MM SZ H, REF 132-32-28 bb. ACUMATCH GXL 15DEG LINER 32MM SZ J, REF 132-32-29 cc. ACUMATCH GXL 15DEG LINER 32MM SZ K, REF 132-32-30 dd.ACUMATCH GXL 15DEG LINER 36MM SZ H, REF 132-36-28 ee. ACUMATCH GXL 15DEG LINER 36MM SZ J, REF 132-36-29 ff. ACUMATCH GXL 15DEG LINER 36MM SZ K, REF 132-36-30 gg. ACUMATCH GXL EXT COV LINER 28MM SZ E, REF 134-28-25 hh. ACUMATCH GXL EXT COV LINER 28MM SZ F, REF 134-28-26 ii. ACUMATCH GXL EXT COV LINER 28MM SZ G, REF 134-28-27 jj. ACUMATCH GXL EXT COV LINER 28MM SZ H, REF 134-28-28 kk. ACUMATCH GXL EXT COV LINER 28MM SZ J, REF 134-28-29 ll. ACUMATCH GXL EXT COV LINER 28MM SZ K, REF 134-28-30 mm. MCS GXL LINER 5/15 DEG 4448X28, REF 104-28-43 nn. MCS GXL LINER 5/15 DEG 5052X28, REF 104-28-44 oo. MCS GXL LINER 5/15 DEG 5458X28, REF 104-28-45 pp. MCS GXL LINER 5/15 DEG 5458X32, REF 104-32-45 qq. MCS GXL LINER 5/15 DEG 6064X32, REF 104-32-46 rr. MCS GXL LINER 5/15 DEG 6064X36, REF 104-36-46 ss. MCS GXL LINER 5/15 DEG 6670X36, REF 104-36-47
Published September 21, 2022 · Recall initiated: August 11, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Exactech, Inc.
- Distributor
- Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN
- Lot
- a. REF 130-28-25, GUDID 10885862021984, Serial Numbers: 802593, 802599, 803717, 803737, 841318, 841321, 1572107, 1579369, 1580046, 1583363, 1613871, 1613872, 1613873, 1618998, 1638490, 1638492, 1638494, 1990100, 2282432, 2282433, 2282434; b. REF 130-28-26, GUDID 10885862021991, Serial Numbers: 801865, 801867, 801870, 801872, 801882, 801883, 801886, 801902, 803686, 803690, 803691, 803694, 803695, 803701, 848210, 848213, 848217, 848221, 848222, 848223, 848226, 848232, 848233, 848236, 1677105, 1677106, 1677108, 1677109, 1677110, 1677112, 1677113, 1677114, 1677115, 1677116, 1677118, 1677119, 1677121, 1677122, 1677123, 1677124, 1677126, 1677127, 1677128, 1677129, 1677130, 1677131, 2515330, 2787553, 3871934, 3871935, 3871943; c. REF 130-28-27, GUDID 10885862022004, Serial Numbers: 801542, 801544, 801546, 801547, 801554, 801571, 801572, 801578, 801580, 804033, 804034, 804035, 804036, 862139, 862144, 862146, 1681578, 1681579, 1681580, 1681581, 1681583, 1703643, 1727491, 1727492, 1727493, 1727495, 1727496, 1727497, 1727498, 1727499, 1727500, 1727501, 1727502, 1727503, 1727504, 1727505, 1727506, 1727507, 1727508; d. REF 130-28-28, GUDID 10885862022011, Serial Numbers: 801765; e. REF 130-28-29, GUDID 10885862022028, Serial Numbers: 801654; f. REF 130-32-27, GUDID 10885862022097, Serial Numbers: 966203, 966204, 966205, 966207, 966208, 966209, 966210, 966211, 966212, 966213, 966215, 966216, 966217, 966218, 966219, 966220, 966221, 966222, 966223, 966224, 966225, 966226, 966227, 966228, 966229, 966230, 966231, 966232, 966233, 1042377, 1042378, 1042379, 1042381, 1042382, 1042383, 1042384, 1042385, 1042387, 1042388, 1042391, 1042392, 1042394, 1042395, 1042396, 1042397, 1042398, 1042399, 1042400, 1042401, 1042402, 1042405, 1042406, 1042407, 1042408, 1095431, 1095432, 1095433, 1095434, 1095435, 1095436, 1095437, 1095438, 1095439, 1095440, 1095441, 1095443, 1095444, 1095445, 1095446, 1095447, 1095448, 1095449, 1095537, 1095538, 1095539, 1095541, 1095542, 1095545, 1095546, 1095547, 1095548, 1095550, 1308088, 1308090, 1308092, 1308093, 1308094, 1308095, 1308096, 1308098, 1308102, 1308103, 1308104, 1308105, 1308106, 1308109, 1308111, 1308113, 1308115, 1308116, 1308117, 1308118, 1308119, 1308120, 1984610, 1984611, 1984612, 1984613, 1984614, 1984616, 2053081, 2075035, 2075037, 2075038, 2075039, 2075040, 2075041, 2075042, 2075043, 2075044, 2075045, 2075046, 2075048, 2075049, 2075050, 2075051, 2398494, 2398496, 2398499, 2517474, 2517476, 2517478, 3818434, 3818437, 3818439, 3818444, 3818447; g. REF 130-32-28, GUDID 10885862022103, Serial Numbers: 966299, 966302, 966305, 966307, 966308, 966312, 966313, 966316, 966317, 966318, 966321, 966322, 966327, 1090743, 1090745; f. REF 130-32-29, GUDID 10885862022110, Serial Numbers: 969025, 969026, 969031, 969043; g. REF 130-36-28, GUDID 10885862022202, Serial Numbers: 967669, 967670, 967671, 967672, 967673, 967674, 967675, 967676, 967677, 967678, 967680, 967681, 967683, 967684, 967685, 967686, 967687, 967688, 967689, 967690, 967691, 967692, 967693, 967694, 967695, 967698, 967699, 967700, 967701, 1051661, 1051662, 1051663, 1051664, 1051665, 1051666, 1051667, 1051669, 1051670, 1085957, 1085959, 1085960, 1085961, 1085962, 1085963, 1085964, 1085965, 1085966, 1116002, 1116003, 1116005, 1116006, 1116007, 1116008, 1116009, 1116010, 1116011, 1116012, 1160079, 1160080, 1160081, 1160082, 1160083, 1160084, 1160085, 1160086, 1160087, 1160089, 1206218, 1206219, 1206223, 1206224, 1206225, 1206226, 1668596, 1668597, 1668598, 1668599, 1668600, 1668601, 1668602, 1668603, 1668604, 1668605, 2112376, 2112377, 2112381, 2112382, 2112383, 2112384, 2140027, 2140028, 2504302, 2537040, 2710341, 3871865, 4984351; h. REF 130-36-29, GUDID 10885862022219, Serial Numbers: 975034, 975035, 975036, 975037, 975038, 975040, 975041, 975042, 975043, 975044, 975046, 975047, 975048, 975049, 975050, 975053, 975054, 975055, 975057, 975059, 975063, 1111355, 1111357, 1111358, 1111359, 1111361, 1121576, 1121578, 1121584, 1300472, 1300476, 1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.