Acumed LLC: Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw AM-0030-S 30.0mm Acutrak¿ 4/5 Bone Screw AM-0035-S 35.0mm Acutrak¿ 4/5

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: Total 306,934 units (Acutrak 239,611 units and Mini Acutrak 67,323) Lot/code info: Acutrak Fusion Device Batch Number/Part Number/Part Description/UDI Code: W73862 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73862000000151231 W73867 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73867000000160130 W73860 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73860000000160131 W73865 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73865000000160131 W73866 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73866000000160131 W73868 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73868000000160131 W73863 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-W73863000000160131 230712 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-230712000000170630 233448 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-233448000000170831 237340 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-237340000000171130 241394 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-241394000000180130 244824 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-244824000000180228 249049 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-249049000000180531 251991 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-251991000000180531 255211 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-255211000000180831 258031 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose 10806378015595-258031000000180930 262000 30-0033-S 3

UPC codes

10806378015595, 10806378055003, 10806378055027, 10806378055041

Source

Official record: FDA (Device enforcement) ↗

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