Exactech, Inc.: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID

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: 17929 units Lot/code info: a. REF 130-32-51, GUDID 10885862207074, Serial Numbers: 2409984, 2409985, 2409986, 2409987, 2409988, 2409989, 2409990, 2409991, 2409993, 2409994, 2409995, 2409996, 2409997, 2409998, 2409999, 2410000, 2410001, 2410002, 2410003, 2410004, 2410005, 2410006, 2410007, 2410008, 2410009, 2410010, 2410011, 2410012, 2410013, 2410014, 2424081, 2424082, 2424083, 2424084, 2424085, 2424086, 2424087, 2424088, 2424089, 2424090, 2424091, 2424092, 2424093, 2424094, 2424096, 2424097, 2424098, 2424099, 2424100, 2433191, 2433192, 2433193, 2433194, 2433195, 2433196, 2433197, 2433198, 2433199, 2433200, 2433201, 2433202, 2433203, 2433204, 2433205, 2433206, 2433207, 2433208, 2433209, 2433210, 2433211, 2581934, 2581935, 2581936, 2581937, 2581938, 2581939, 2581940, 2581941, 2581942, 2581943, 2581944, 2581945, 2581946, 2581947, 2581948, 2581950, 2581951, 2581952, 2581953, 2581954, 2581955, 2581956, 2581957, 2581958, 2581959, 2581960, 2581961, 2581962, 2581963, 2581964, 2581965, 2581966, 2581967, 2581968, 2581969, 2581970, 2581971, 2581972, 2581973, 2581974, 2581975, 2581976, 2581977, 2581978, 2581979, 2581980, 2581981, 2581982, 2581983, 2674321, 2674322, 2674323, 2674324, 2674325, 2674326, 2674327, 2674328, 2674329, 2674330, 2674331, 2674332, 2674333, 2674334, 2674335, 2674336, 2674337, 2674338, 2674339, 2674340, 2674341, 2674342, 2674343, 2674344, 2674345, 2674346, 2674347, 2674348, 2674349, 2674350, 2674351, 2674352, 2674354, 2674355, 2674356, 2674357, 2674358, 2674359, 2674360, 2674361, 2674362, 2674

UPC codes

10885862207074

Source

Official record: FDA (Device enforcement) ↗

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