RecallRadar

FDA Device recall Z-1731-2022

GXL acetabular liners, orthopedic hip implant component

On 2022-09-21 the FDA classified a Class II recall of GXL acetabular liners, orthopedic hip implant component by Exactech, citing specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1731-2022
ClassificationClass II
Statusongoing
Initiated2022-08-11
Published2022-09-21
Last updated2026-09-13 11:56 UTC
CompanyExactech
DistributionUS

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.

Identifiers

code_info
a. 130-28-50, GUDID 10885862022059, Serial Numbers: 1784995, 1784996, 1784998, 1785000, 1785002, 1785003, 1785006, 178…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, 36

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1731-2022%22

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