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FDAFDA · Food and drugs·Recall number Z-1218-2024

Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate Long, Left; 70-0047-S Acu-Loc VDU Plate Long, Left; 70-0048 Acu-Loc VDU Plate Long, Right; 70-0048-S Acu-Loc VDU Plate Long, Right; 70-0055 Acu-Loc Dorsal Plate, Standard, left; 70-0055-S Acu-Loc Dorsal Plate, Standard, left; 70-0056 Acu-Loc Dorsal Plate, Standard, Right; 70-0056-S Acu-Loc Dorsal Plate, Standard, Right; 70-0057 Acu-Loc Dorsal Plate, Narrow, Left; 70-0057-S Acu-Loc Dorsal Plate, Narrow, Left; 70-0058 Acu-Loc Dorsal Plate, Narrow, Right; 70-0058-S Acu-Loc Dorsal Plate, Narrow, Right; 70-0331 Divergent Radial Styloid Plate; 70-0331-S Divergent Radial Styloid Plate; 70-0334 Volar Lunate Suture Plate; 70-0334-S Volar Lunate Suture Plate; 70-0335 Dorsal Rim Buttress Plate, Right; 70-0335-S Dorsal Rim Buttress Plate, Right; 70-0336 Dorsal Rim Buttress Plate, Left; 70-0336-S Dorsal Rim Buttress Plate, Left; 70-0337 Dorsal Lunate Plate, Right; 70-0337-S Dorsal Lunate Plate, Right; 70-0338 Dorsal Lunate Plate, Left;

Published March 6, 2024 · Recall initiated: December 19, 2023

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Distribution without Pre-Market Clearance

What to do

Voluntary: Firm initiated

Recall details

Manufacturer
Acumed LLC
Distributor
Worldwide distribution - US Nationwide and the countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, ID, IE, IL, IT, JP, KR, KW, MX, MY, NZ, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, US, ZA.
Lot
All Lots; REF Number /UDI Number: 30-0100 10806378094637-331500000000 30-0100 10806378094637-342124000000 30-0100 10806378094637-347940000000 30-0100 10806378094637-369580000000 30-0100 10806378094637-379903000000 30-0100 10806378094637-404624170313 30-0100 10806378094637-414434170728 30-0100 10806378094637-421189171027 30-0100 10806378094637-428663180115 30-0100 10806378094637-438740180329 30-0100 10806378094637-449053180822 30-0100 10806378094637-462420190205 30-0100 10806378094637-476011190723 30-0100 10806378094637-484283191107 30-0100 10806378094637-486858191209 30-0100 10806378094637-489970200120 30-0100 10806378094637-489971200120 30-0100 10806378094637-514064201119 30-0100 10806378094637-526968210426 30-0100 10806378094637-542934210920 30-0100 10806378094637-549407211124 30-0100 10806378094637-559130220324 30-0100 10806378094637-559131220324 30-0100 10806378094637-564636220526 30-0100 10806378094637-564637220526 30-0100 10806378094637-564638220526 30-0100 10806378094637-574209220928 30-0100 10806378094637-574210220928 30-0100 10806378094637-574211220928 30-0100 10806378094637-575356221011 30-0100 10806378094637-331499000000 30-0100 10806378094637-331500A170802 30-0100-S 10806378094644-412714170509240508 30-0100-S 10806378094644-490822200128270127 30-0100-S 10806378094644-564641220526290525 30-0100-S 10806378094644-564642000000 30-0100-S 10806378094644-565035220603290602 30-0100-S 10806378094644-574212220928290927 30-0100-S 10806378094644-574213000000 30-0100-S 10806378094644-574949221005291004 30-0100-S 10806378094644-583160230105300104 30-0218-S 10806378016004-299836000000200531 30-0218-S 10806378016004-300179000000200531 30-0218-S 10806378016004-300180000000200630 30-0218-S 10806378016004-300905000000200731 30-0218-S 10806378016004-379941160428230428 30-0218-S 10806378016004-417738170802240801 30-0218-S 10806378016004-463671190307260306 30-0218-S 10806378016004-485336191119261118 30-0218-S 10806378016004-495321200317270317 30-0218-S 10806378016004-502483200622270622 30-0218-S 10806378016004-548427211111281110 30-0218-S 10806378016004-564308220524290523 30-0219-S 10806378016011-300236000000200531 30-0219-S 10806378016011-300237000000200531 30-0219-S 10806378016011-355799000000220630 30-0219-S 10806378016011-370053151214221213 30-0219-S 10806378016011-379918160428230428 30-0219-S 10806378016011-391966160906230906 30-0219-S 10806378016011-408883170330240329 30-0219-S 10806378016011-419189170816240815 30-0219-S 10806378016011-432195180123250122 30-0219-S 10806378016011-442783180604250603 30-0219-S 10806378016011-447826180807250821 30-0219-S 10806378016011-457256181227251226 30-0219-S 10806378016011-463672190308260307 30-0219-S 10806378016011-464499190318260317 30-0219-S 10806378016011-470100190507260506 30-0219-S 10806378016011-481591191008261007 30-0219-S 10806378016011-489803200116270115 30-0219-S 10806378016011-497833200415270415 30-0219-S 10806378016011-503940200714270714 30-0219-S 10806378016011-520665210223280223 30-0219-S 10806378016011-533154210629280628 30-0219-S 10806378016011-548216211109281108 30-0219-S 10806378016011-548217211109281108 30-0219-S 10806378016011-562822220504290503 30-0219-S 10806378016011-564367220525290524 30-0219-S 10806378016011-565036000000 30-0219-S 10806378016011-584975230127300126 30-0219-S 10806378016011-598056230920300919 30-0219-S 10806378016011-598163230920300919 30-0219-S 10806378016011-598257230922300921 30-0220-S 10806378016028-540659210831280830 30-0220-S 10806378016028-300238000000200531 30-0220-S 10806378016028-300250000000200531 30-0220-S 10806378016028-355814000000220630 30-0220-S 10806378016028-372336160121230120 30-0220-S 10806378016028-382115160526230526 30-0220-S 10806378016028-394903161010231010 30-0220-S 10806378016028-409029170330240329 30-0220-S 10806378016028-426444000000 30-0220-S 10806378016028-426817171120241119 30-0220-S 10806378016028-438533180408250407 30-0220-S 10806378016028-444144180613250621 30-0220-S 10806378016028-450830180927250926 30-0220-S 1080637801
Risk classification
Class II
Area (FDA)
device
Country
United States

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