Acumed LLC: Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 30-0021-S 25.0mm Acutrak 2¿ - 5.5 Screw 30-0023 30.0mm Acutrak 2¿ - 5.5 Screw 30-0023-S 30.0mm Acutrak 2¿ - 5.

Hazard

Distribution without Pre-Market Clearance

Details from the source

Reason for recall: Distribution without Pre-Market Clearance Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY. The countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, IE, IL, IT, JP, KR, KW, Quantity: 1,681,860 units (Acutrak 2 286,026; Micro Acutrak 2 524,566; Mini Acutrak 2 609,220; Standard Acutrak 262,048) Lot/code info: Acutrak 2 Fusion Device Batch Number/Part Number/Part Description/UDI Code: W74030 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-W74030000000 204349 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-204349000000 207092 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-207092000000 208497 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-208497000000 207877 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-207877000000 208095 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-208095000000 209948 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-209948000000 210146 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-210146000000 212410 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-212410000000 210147 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-210147000000 214004 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-214004000000 212916 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-212916000000 215249 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-215249000000 216130 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-216130000000 269589 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-269589000000 273212 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-273212000000 275237 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-275237000000 279567 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-279567000000 280672 30-0021 25.0mm Acutrak 2¿ - 5.5 Screw 10806378015366-280672000000 286762 30-0021 25.0mm Acutrak 2¿ - 5.

UPC codes

10806378015366, 204349000000, 207092000000, 208497000000, 207877000000, 208095000000, 209948000000, 210146000000, 212410000000, 210147000000, 214004000000, 212916000000, 215249000000, 216130000000, 269589000000, 273212000000, 275237000000, 279567000000, 280672000000, 286762000000, 292375000000, 297811000000, 298112000000, 301151000000, 300366000000, 302325000000, 350026000000, 356311000000, 377077000000, 401842170130, 423327171110, 428018171228, 459563190114, 469615190429, 477574190813, 484366191107, 514186201121, 526705210422, 10806378015373, 224822000000

Source

Official record: FDA (Device enforcement) ↗

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