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FDA (Device enforcement)Recalled 2024-12-31class ii

Exactech, Inc.: AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H 32MM 140-28-29 AM EHXL 0¿ LNR J 28MM 140-32-2

Hazard

Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

Details from the source

Reason for recall: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. Distribution: U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain Quantity: 42 Lot/code info: Item Number / Product Description/ UDI-DI code: 140-28-27 AM EHXL 0¿ LNR G 28MM 10885862537997 140-32-27 AM EHXL 0¿ LNR G 32MM 10885862538031 140-32-28 AM EHXL 0¿ LNR H 32MM 10885862538048 140-28-29 AM EHXL 0¿ LNR J 28MM 10885862538017 140-32-29 AM EHXL 0¿ LNR J 32MM 10885862538055 140-36-29 AM EHXL 0¿ LNR J 36MM 10885862538086 140-32-30 AM EHXL 0¿ LNR K 32MM 10885862538062 140-36-30 AM EHXL 0¿ LNR K 36MM 10885862538093 140-28-25 AM EHXL 0¿LNR E 28MM 10885862537973 140-28-26 AM EHXL 0¿LNR F 28MM 10885862537980 140-28-28 AM EHXL 0¿LNR H 28MM 10885862538000 140-36-28 AM EHXL 0¿LNR H 36MM 10885862538079 140-28-30 AM EHXL 0¿LNR K 28MM 10885862538024 142-28-24 AM EHXL 15¿ LNR D 28MM 10885862538123 142-28-26 AM EHXL 15¿ LNR F 28MM 10885862538147 142-32-27 AM EHXL 15¿ LNR G 32MM 10885862538192 142-32-28 AM EHXL 15¿ LNR H 32MM 10885862538208 142-36-28 AM EHXL 15¿ LNR H 36MM 10885862538239 142-36-29 AM EHXL 15¿ LNR J 26MM 10885862538246 142-28-29 AM EHXL 15¿ LNR J 28MM 10885862538178 142-32-29 AM EHXL 15¿ LNR J 32MM 10885862538215 142-28-30 AM EHXL 15¿ LNR K 28MM 10885862538185 142-32-30 AM EHXL 15¿ LNR K 32MM 10885862538222 142-36-30 AM EHXL 15¿ LNR K 36MM 10885862538253 142-28-25 AM EHXL 15¿LNR E 28MM 10885862538130 142-28-27 AM EHXL 15¿LNR G 28MM 10885862538154 142-28-28 AM EHXL 15¿LNR H 28MM 10885862538161 144-28-28 AM EHXL EXT LNR H 28MM 10885862538291 144-28-29 AM EHXL EXT LNR J 28MM 10885862538307 144-28-25 AM EHXL EXTLNR E 28MM 10885862538260 144-28-26 AM EHXL EXTLNR F 28MM 10

UPC codes

10885862537997, 10885862538031, 10885862538048, 10885862538017, 10885862538055, 10885862538086, 10885862538062, 10885862538093, 10885862537973, 10885862537980, 10885862538000, 10885862538079, 10885862538024, 10885862538123, 10885862538147, 10885862538192, 10885862538208, 10885862538239, 10885862538246, 10885862538178, 10885862538215, 10885862538185, 10885862538222, 10885862538253, 10885862538130, 10885862538154, 10885862538161, 10885862538291, 10885862538307, 10885862538260, 10885862538277, 10885862538284, 10885862538314, 10885862538338, 10885862538345, 10885862538383, 10885862538390, 10885862538376, 10885862538406, 10885862538321

Source

Official record: FDA (Device enforcement)

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

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