Boston Scientific Neuromodulation Corporation: Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 1

Hazard

As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.

Details from the source

Reason for recall: As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device. Distribution: 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, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. Quantity: 70,516 Lot/code info: Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 ALL Lot/Batch Number: 40280174 40145632 40117221 40113198 40113255 40113385 40113391 40113482 40106856 40027385 26176977 800276 800301 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 ALL Lot/Batch Numbers: 40222297 40213592 40199967 40198809 40195249 40186649 40181505 40166300 40157622 40141657 40141770 40136859 40131798 40132036 40112806 40106870 40093564 40080016 40080111 40076497 40070306 40070307 40052009 40045101 40034339 40027338 40027364 40022398 40018296 40018338 40010128 40004038 40004068 40000647 30244690 30178729 29985230 29849515 29849969 29668712 29668713 29578948 29578949 29360265 29360263 29360264 29160559 29160625 28756501 28627193 28627192 28627194 28501592 28501591 28501593 28344375 28344376 28344377 28133122 800279 800345 800269 800278 800268 800280 800261 800270 700089 800259 800260 800258 800250 800317 800318 700085 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 ALL Lot/Batch Numbers: 40280071 40245960 40222355 40211234 40211404 40211463 40199117 40199211 40186760 40165937 40157506 40157279 40139759 40140041 40132011 40129328 40114193 40114290 40106757 40106924 40093299 40093565 40080015 40080124 40070323 40051777 40045673 40045706 40044635 40045080 40027314 40027337 40027346 40018297 40018311 40018344 40018360 40010112 40010126 40010144 40004051 40004081 40003228 40000665 30244396 30244397 29985232 29985233 29927

UPC codes

00884662000529, 00884662000536, 00884662000543, 00884662000550, 00884662000567, 00884662000574, 00884662000611

Source

Official record: FDA (Device enforcement) ↗

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