Acumed LLC: AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTw

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: 80,805 units Lot/code info: AcuTwist Acutrak Compression Device Batch Number/Part Number/Part Description/UDI Code: 204010 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-204010000000160531 219050 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-219050000000170130 226652 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-226652000000170531 236972 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-236972000000171231 239079 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-239079000000180131 260403 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-260403000000181231 265390 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-265390000000190228 270950 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-270950000000190331 273603 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-273603000000190731 278305 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-278305000000190930 358993 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-358993000000220731 358079 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-358079150903220902 404026 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-404026170131240131 411204 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-411204170418240417 412910 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-412910170728240727 417672 AI-0010-S 10mm AcuTwist¿

UPC codes

10806378054501, 10806378054525, 10806378054549, 10806378054563, 10806378054587, 10806378054594, 347469000000, 352881000000, 357435000000, 360895000000, 360896000000, 360983000000, 380559170717, 383861000000, 385662000000, 428469180521, 453559000000, 458446181231, 524631210331, 528174210510, 540216210824, 540215210824, 10806378054600, 10806378054624, 10806378054648, 10806378054655, 347470000000, 352882000000, 360897000000, 360898000000, 360984000000, 380560000000, 383862000000, 385663000000, 426682180511, 430694171219, 453847181025, 527545210503, 533900210707, 537102210803

Source

Official record: FDA (Device enforcement) ↗

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