Exactech Equinoxe Reverse Shoulder System recall
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)…
Why was Exactech Equinoxe Reverse Shoulder System recalled?
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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)…
- Recalling firm
- Exactech, Inc.
- Quantity
- N/A
- Distribution
- 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
- Recall date
- December 27, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)