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

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilitya. 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, 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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 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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.

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.

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