Exactech, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0579-2024)

Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n) 320-46-13

Class II

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

a) 320-36-00, GTIN 10885862086617, Serial Numbers: A641190, A641191, A641194, A641202, A641203, A641215, A641221, A641222, A641223, A641224, A641225, A641228, A641229, A641230, A641232, A641233, A641235, A641237, A641238, A641239, A641240, A641241, A641242, A641244, A641245, A641246, A641247, A680944, A689543, A689544, A689545, A689549, A689553, A689557, A689560, A689565, A689572, A706598, A706612, A706630, A706631, A706639, A706641; b) 320-36-03, GTIN 10885862086624, Serial Numbers: A640183, A640186, A640188, A640190, A640193, A640195, A640196, A640198, A677718, A677727, A677728, A677731, A677732, A677751, A685284, A685289, A685290, A685291, A685292, A685295, A685296, A685298, A685299, A685300, A685301, A685303, A685305, A685306, A685310, A685312, A685315, A685317, A685318, A685319, A685320, A685323, A685326, A685327, A685337, A685338, A685346, A685350, A685351, A685361, A685362, A685363, A685369, A685375, A685377, A685379, A695083, A695088, A695098, A695107, A695120, A695122; c) 320-36-04, GTIN 10885862086624, Serial Numbers: A685325; d) 320-36-10, GTIN 10885862086631, Serial Numbers: A695123, A695124, A695125, A695126, A695127, A695129, A695130, A695131, A695132, A695137, A695140, A695146, A695150, A695151, A695152, A695154, A695155, A695157, A695159, A695160, A695161, A695162, A695165, A695166, A695167, A695168, A716197, A716219, A716230, A716231, A716232, A716233, A716234, A716236; e) 320-36-13, GTIN 10885862086648, Serial Numbers: A696430, A696435, A696436, A696438, A696441, A696443, A696444, A696445, A696446, A696447, A696449, A696450, A696452, A696455, A696458, A696459, A696460, A696461, A696462, A696466, A696469, A696471, A696472, A696473, A696474, A696475, A696477; f) 320-38-00, GTIN 10885862086655, Serial Numbers: A738779, A738799, A738822, A738823, A738846, A738847, A738848, A738849, A738850; g) 320-38-13, GTIN 10885862086686, Serial Numbers: A679891; h) 320-40-00, GTIN 10885862535030, Serial Numbers: A641613, A641619, A641623, A641624, A641626, A641629, A641631, A641632, A688976, A688977, A688981, A688982, A688983, A688984, A688985, A688986, A688989, A688990, A688991, A688992, A688993, A688994, A688997, A688999, A689001, A689002, A689003, A689004, A689008, A689011, A689015, A689016, A689017, A689018, A689019, A689021, A689022, A689023, A689025, A715756, A715757, A715758, A715760, A715762, A715763, A715764, A715766, A715768, A715771, A715775, A750496, A750497, A750499, A750502, A750511, A750524, A750529; i) 320-40-10, GTIN 10885862535054, Serial Numbers: A689439, A689441, A689442, A689445, A689448, A689449, A689452, A689453, A689456, A689459, A689461, A689465, A689475, A689476; j) 320-42-00, GTIN 10885862086693, Serial Numbers: A639962, A639964, A639965, A639966, A639967, A639977, A639978, A639979, A639984, A639986, A639989; k) 320-42-10, GTIN 10885862086716, Serial Numbers: A685535, A685539, A685551, A685557, A685568, A685573; l) 320-42-13, GTIN 10885862086723, Serial Numbers: A677654, A677663, A677675, A677683, A677690, A677691, A677692, A677698; m) 320-46-10, GTIN 10885862086754, Serial Numbers: A638847, A638848, A638849, A677703, A677704, A677707, A677708, A677712; n) 320-46-13, GTIN 10885862086761, Serial Numbers: A662094, A685620, A685624, A685627, A773694, A773700, A773702

US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK

Voluntary: Firm initiated