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FDA (Device enforcement)Recalled 2022-11-29class ii

Acumed LLC: Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicl

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: 7,498 units Lot/code info: Dual-Trak Clavicle Screws: Batch Number/Part Number/Part Description/UDI Code: 237352 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-237352000000 241396 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-241396000000 251499 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-251499000000 273721 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-273721000000 295968 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-295968000000 305419 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-305419000000 320123 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-320123000000 320365 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-320365000000 320998 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-320998000000 353959 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-353959000000 360734 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-360734000000 361151 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-361151000000 376436 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-376436000000 377113 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-377113000000 379009 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-379009000000 379939 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-379939000000 379920 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-379920000000 410141 40-0136 3.0mm x 80mm Dual-Trak Clavic

UPC codes

10806378028410, 237352000000, 241396000000, 251499000000, 273721000000, 295968000000, 305419000000, 320123000000, 320365000000, 320998000000, 353959000000, 360734000000, 361151000000, 376436000000, 377113000000, 379009000000, 379939000000, 379920000000, 410141170413, 410142170413, 423108171009, 423212171009, 441951180523, 442003180524, 477282190808, 477323190809, 500931200601, 501581200610, 525006210405, 525005210405, 525007210405, 525102210406, 525505210412, 556268220222, 556269220222, 556358220223, 10806378028427, 10806378028434, 241398000000, 251500000000

Source

Official record: FDA (Device enforcement)

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

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