Recall archive / FDA device enforcement
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-... — FDA record Z-1731-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 11, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
- Reason
- Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
- Classification
- Class II
- Recalling firm
- Exactech, Inc.
- Quantity
- 3793 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1731-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a. 130-28-50, GUDID 10885862022059, Serial Numbers: 1784995, 1784996, 1784998, 1785000, 1785002, 1785003, 1785006, 1785011, 1785012, 1785013, 1785015, 1785016, 1785017, 1785018, 1785022, 1785024, 1785026, 1785027, 1785030, 1785032, 1785033, 1796637, 1796640, 1796641, 1796642, 1796644, 1796647, 1796652, 1796654, 1796655, 1796656, 1796658, 1810811, 1810813, 1810814, 1810818, 1810819, 1810821, 1810822, 1810825, 1810828, 1810829, 1810831, 1810832, 1859562, 2540144, 2540145, 2540146, 2540147, 2540148, 2540150, 2633432, 2633433, 2691744, 2691746, 2691747, 2691748, 2691749, 2691750, 2691751, 2691752, 2707045, 2707047, 2707048, 2707049, 2707050, 2800307, 2800308, 2812276, 2812277, 2893670, 2893671, 2893672, 2976865, 2976866, 2976867, 2976868, 2976869, 3544420, 3544421, 3544422, 3544423, 3544424, 3544431, 3544432, 3544435, 3544437, 3544439, 3544442, 3544444, 3544445, 3544446, 3544447, 3544450, 3673569, 3673571, 3673572, 3673573, 3673574, 3673575, 3673577, 3673578, 3673579, 3673581, 3673583, 3673586, 3673587, 3673588, 3673589, 3673592, 3673593, 3673594, 3673595, 3673596, 3673597, 3673598, 3673599, 3673600, 3712228, 3712229, 3712230, 3712231, 3712232, 3712234, 3712236, 3712238, 3712239, 3712241, 3712455, 3712457, 3712458, 3712459, 3712460, 3712462, 3712463, 3744701, 3744702, 3744703, 3744704, 3744705, 3744706, 3744707, 3744708, 3744710, 3744713, 3744714, 3744715, 3744716, 3744717, 3744718, 3744720, 3744722, 3744723, 3744724, 3978806, 3978807, 3978808, 3978810, 3978811, 3978815, 3978817, 3978818, 3978819, 3978820, 3978822, 3978823, 3978824, 3978825, 4142832, 4142836, 4142837, 4142838, 4142842, 4142845, 4142846, 4142847, 4142848, 4142851, 4142854, 4383613, 4383614, 4383615, 4383617, 4383618, 4383620, 4383622, 4383623, 4383624, 4383625, 4383626, 4383628, 4383629, 4383630, 4383631, 4383632, 4383633, 4383634, 4383635, 4383637, 4383638, 4383639, 4478739, 4478740, 4478741, 4478742, 4478743, 4478744, 4478746, 4478747, 4478750, 4478753, 4478754, 4478756, 4478757, 4478758, 4478762, 4478763, 4478764, 4673689, 4673690, 4673692, 4673693, 4673694, 4673695, 4673696, 4673699, 4673700, 4673701, 4699019, 4699020, 4699021, 4699022, 4699023, 4727112, 4727113, 4727114, 4727115, 4727116, 4727117, 4770113, 4770116, 4770117, 4770118, 4770119, 4770120, 4770121, 4770122, 4788829, 4788830, 4788831, 4788832, 4788833, 4788835, 4788836, 4788838, 4813711, 4813712, 4813713, 4813716, 4836757, 4836758, 4836759, 4836760, 4836761, 4836762, 4836763, 4836764, 4836765, 4836766, 4836767, 4836768, 4836769, 4836770, 4836771, 4836773, 4845642, 4845643, 4845644, 4845645, 4845646, 4845647, 4845648, 4845649, 4845650, 4845651, 4845652, 4845653, 4845654, 4845655, 4845656, 4845657, 5027363, 5027364, 5027365, 5027366, 5027367, 5027368, 5027369, 5027371, 5027372, 5092203, 5092207, 5092209, 5092210, 5092211, 5092212, 5133514, 5133515, 5133516, 5133517, 5133518, 5133519, 5133520, 5133521, 5133522, 5133523, 5138402, 5138403, 5138405, 5138406, 5138407, 5138408, 5138409, 5138411, 5192509, 5192510, 5192511, 5192512, 5192513, 5192514, 5192515, 5192518, 5265341, 5265343, 5265346, 5265347, 5265349, 5265350, 5265356, 5265357, 5265359, 5265360, 5265361, 5265362, 5265364, 5469670, 5469671, 5469672, 5469674, 5469677, 5469678, 5469681, 5469682, 5469684, 5469685, 5469687, 5469688, 5525315, 5525316, 5525317, 5525318, 5525319, 5525320, 5525321, 5556531, 5556532, 5556533, 5556534, 5556536, 5556537, 5556539, 5556540, 5556543, 5556544, 5556546, 5556547, 5556550, 5556551, 5556553, 5768901, 5768903, 5768906, 5768908, 5768911, 5768912, 5768915, 5768917, 5768918, 5768919, 5768923, 5768924, 5921794, 5921796, 5921798, 5921802, 5921804, 5921805, 5921807, 5921811, 5921815, 5921816, 5921817, 5921819, 6664657; b. 130-22-70, GUDID 10885862021892, Serial Numbers: 1787743, 1787757, 1787758, 1787764, 2827594, 2827595, 2827596, 2827597, 2827598, 2827599, 2827600, 2827601, 2827602, 2827603, 2827604, 2827605, 2827606, 2827607, 2827608, 2827609, 2827610, 2900032; c. 132-28-50, GUDID 10885862023148, Serial Numbers: 1785082, 1785083, 1785084, 1785088, 1785089, 1785091, 1785092, 1785096, 1785097, 1785098, 1785099, 1785100, 1785101, 1785106, 1785108, 1785110, 1785115, 1785117, 1785119, 1785120, 1785121, 1785122, 1785123, 1797031, 1797032, 1797033, 1797034, 1797035, 1797039, 1797041, 1797042, 1797043, 1797046, 1797047, 1797050, 1811551, 1811552, 1811553, 1811554, 1811556, 1811557, 1811559, 1811560, 1811561, 1811563, 1811564, 1811565, 1811566, 1811567, 1811568, 1811569, 1852506, 1852507, 1852508, 1852509, 1852512, 1852513, 1852515, 1852516, 1852517, 1852518, 1852519, 1852520, 1870759, 1870760, 1870761, 1870762, 1870764, 1870765, 1870766, 1870767, 1870768, 1870769, 1870770, 2133603, 2133604, 2133605, 2133606, 2133607, 2133608, 2133609, 2133610, 2133611, 2133612, 2133613, 2133614, 2133615, 2133616, 2133617, 2133618, 2133619, 2133620, 2133621, 2133622, 2133624, 2133625, 2133626, 2133627, 2133629, 2133630, 2158036, 2158037, 2158038, 2158039, 2158040, 2158041, 2158042, 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2479920, 2479921, 2479922, 2479923, 2479924, 2479925, 2479926, 2479927, 2479928, 2479929, 2479930, 2479931, 2479932, 2479933, 2479934, 2479935, 2479936, 2479937, 2479938, 2479939, 2479940, 2479941, 2479942, 2479943, 2506614, 2506615, 2506616, 2506617, 2506618, 2506619, 2506620, 2506621, 2506622, 2506623, 2506624, 2506625, 2506626, 2506627, 2506628, 2506629, 2506630, 2506631, 2506632, 2506633, 2506634, 2506635, 2506636, 2506637, 2506638, 2506639, 2506640, 2506641, 2506642, 2506643, 2506644, 2506645, 2506646, 2506647, 2506648, 2506649, 2506650, 2506651, 2506652, 2506653, 2506654, 2506655, 2506656, 2574470, 2574471, 2574472, 2574473, 2574474, 2574475, 2574476, 2574477, 2574478, 2574479, 2574480, 2574481, 2574482, 2574483, 2574484, 2574485, 2655103, 2655104, 2655105, 2655107, 2655108, 2655109, 2655110, 2667683, 2667685, 2667686, 2680108, 2680109, 2680110, 2680111, 2691767, 2691768, 2691769, 2691770, 2691771, 2691772, 2691773, 2691774, 2691775, 2691777, 2691778, 2691779, 2691780, 2691781, 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2815983, 2815985, 2815986, 2815987, 2815989, 2815990, 2815991, 2815992, 2815995, 2815996, 2815997, 2815998, 2815999, 2818660, 2818661, 2818662, 2818663, 2818664, 2818665, 2818666, 2818667, 2818668, 2818669, 2818670, 2818671, 2818672, 2818673, 2818674, 2818675, 2818676, 2818677, 2871793, 2871794, 2871795, 2871796, 2871797, 2871798, 2871799, 2871800, 2871801, 2871802, 2871803, 2871804, 2871805, 2871806, 2871807, 2871808, 2871809, 2871810, 2871811, 2871812, 2871813, 2871814, 2871815, 2871817, 2871818, 2871819, 2871820, 2871821, 2871822, 2923594, 2923595, 2923596, 2923597, 2923598, 2923599, 2923600, 2923601, 2923602, 2923603, 2923604, 2923605, 2923606, 2923607, 2923608, 2923609, 2923610, 2923611, 2923612, 2923613, 2923614, 2923615, 2923616, 2923617, 2923618, 2923619, 2923620, 2923621, 2923622, 2923623, 2956982, 2956983, 2956984, 2956985, 2956986, 2956987, 2956988, 2956989, 2956990, 2956991, 2956992, 2956993, 2956994, 2956995, 2956996, 2956997, 2956998, 2956999, 2957000, 2957001, 2957002, 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3658136, 3658137, 3658138, 3658139, 3658140, 365814... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 21, 2022
- Recall initiation date
- Aug 11, 2022
- Center classification date
- Sep 9, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.