Acumed LLC: 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 P

Hazard

Distribution without Pre-Market Clearance

Details from the source

Reason for recall: Distribution without Pre-Market Clearance Distribution: 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. Quantity: 2,952,121 units Lot/code info: 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 1080637

UPC codes

10806378094637, 331500000000, 342124000000, 347940000000, 369580000000, 379903000000, 404624170313, 414434170728, 421189171027, 428663180115, 438740180329, 449053180822, 462420190205, 476011190723, 484283191107, 486858191209, 489970200120, 489971200120, 514064201119, 526968210426, 542934210920, 549407211124, 559130220324, 559131220324, 564636220526, 564637220526, 564638220526, 574209220928, 574210220928, 574211220928, 575356221011, 331499000000, 10806378094644, 564642000000, 574213000000, 10806378016004, 10806378016011, 565036000000, 10806378016028, 426444000000

Source

Official record: FDA (Device enforcement) ↗

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