Exactech, Inc.: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP

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: 2319 devices Lot/code info: a. REF 134-28-41, GUDID 10885862023971, Serial Numbers: 1152706, 1152707, 1152709, 1152711, 1152712, 1152713, 1152714, 1152716, 1152717, 1152719, 1152721, 1152722, 1152724, 1152725, 1338587, 1338588, 1338589, 1338590, 1338592, 1338593, 1338594, 1338595, 1338598, 1338599, 1338600, 1338601, 1338602, 1338603, 1338604, 1504513, 1504516, 1514969, 1514972, 1521171, 1521172, 1521173, 1521174, 1521175, 1521176, 1521177, 1521178, 1521179, 1521180, 1521181, 1665721, 1665722, 1665723, 1665724, 1665725, 1665728, 1665730, 1665732, 1665733, 1665734, 1665735, 1665737, 1665738, 1821757, 1821758, 1821759, 1821762, 1821763, 1821764, 1834478, 1834479, 1834480, 1834481, 1834482, 1834483, 1834484, 1834486, 1834487, 1916424, 1916425, 1916426, 1916428, 1916429, 1916430, 1916431, 1916432, 1916433, 1916434, 1916435, 1916436, 1916437, 1916438, 1916439, 1916440, 1916441, 2023328, 2023329, 2023330, 2023331, 2023332, 2023333, 2048938, 2048939, 2049268, 2064326, 2064327, 2064328, 2064329, 2064330, 2064332, 2067222, 2067223, 2067224, 2067225, 2067226, 2149352, 2149353, 2149354, 2149355, 2149356, 2149358, 2149359, 2149360, 2149361, 2149362, 2149363, 2166650, 2166651, 2166652, 2166653, 2166654, 2166655, 2166656, 2166657, 2166658, 2166659, 2166660, 2166661, 2166662, 2166663, 2166664, 2231542, 2231543, 2231544, 2231545, 2231546, 2231547, 2231548, 2231549, 2231550, 2231551, 2231552, 2231553, 2231555, 2231556, 2231557, 2231558, 2231559, 2231560, 2231561, 2231562, 2231563, 2276260, 2276261, 2276262, 2276263, 2276

UPC codes

10885862023971, 10885862023988, 10885862024022, 10885862024039, 10885862024046

Source

Official record: FDA (Device enforcement) ↗

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