Exactech, Inc.: 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

Hazard

Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

Details from the source

Reason for recall: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. Distribution: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN Quantity: 11143 DEVICES Lot/code info: 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, 966

UPC codes

10885862021984, 10885862021991, 10885862022004, 10885862022011, 10885862022028, 10885862022097, 10885862022103, 10885862022110, 10885862022202, 10885862022219, 10885862022226, 10885862024589, 10885862024596, 10885862024602, 10885862024619, 10885862024626, 10885862024824, 10885862024831, 10885862024848, 10885862024817, 10885862023063, 10885862023070, 10885862023087

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.