FDAFDA · Alimentos y medicamentos·N.º oficial Z-2948-2020
PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT CHROME PHAC1214 PROFEMUR NECK A/R VAR/VAL 2 LONG COBALT CHROME PHAC1222 PROFEMUR NECK A/R VAR/VAL 1 SHORT COBALT CHROME PHAC1224 PROFEMUR NECK A/R VAR/VAL 1 LONG COBALT CHROME PHAC1232 PROFEMUR NECK A/R 8DG SHORT COBALT CHROME PHAC1234 PROFEMUR NECK A/R 8DG LONG COBALT CHROME PHAC1242 PROFEMUR NECK A/R 15DG SHORT COBALT CHROME PHAC1244 PROFEMUR NECK A/R 15DG LONG COBALT CHROME PHAC1252 PROFEMUR NECK VAR/VAL 8DG SHORT COBALT CHROME PHA01202 PROFEMUR NECK NEUTRALSHORT SHORT PHA01204 PROFEMUR NECK NEUTRAL LONG PHA01206 PROFEMUR NECK NEUTRAL X LONG PHA01212 PROFEMUR NECK A/R VAR/VAL 2 SHORT PHA01214 PROFEMUR NECK A/R VAR/VAL 2 LONG PHA01222 PROFEMUR NECK A/R VAR/VAL 1 SHORT PHA01224 PROFEMUR NECK A/R VAR/VAL 1 LONG PHA01232 PROFEMUR NECK 8DG A/R SHORT PHA01234 PROFEMUR NECK 8DG A/R LONG PHA01236 PROFEMUR NECK 8DG A/R X LONG PHA01242 PROFEMUR NECK 15DG A/R SHORT PHA01244 PROFEMUR NECK 15DG A/R LONG PHA01252 PROFEMUR NECK 8DG VAR/VAL SHORT PHA01254 PROFEMUR NECK 8DG VAR/VAL LONG PHA01256 PROFEMUR NECK 8DG VAR/VAL X LONG PHA01262 PROFEMUR NECK 15DG VAR/VAL SHORT PHA01264 PROFEMUR NECK 15DG VAR/VAL LONG Intended Use: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Publicado el 16 de septiembre de 2020 · Inicio del retiro: 31 de julio de 2020
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR¿ Hip System Package Insert with the most recent revision (150803-8).
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- MicroPort Orthopedics Inc.
- Distribuidor
- Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MO, MT, NC, NH, NJ, NV, OH, PA, TN, TX, UT, VA, WA, WI including PR; and countries of: Brazil, Canada, China, Costa Rica, France, Germany, Japan, The Netherlands and United Kingdom.
- Lote
- All lots 1431860 1435705 1430154 1431065 1431308 1436522 1437003 0298131491437686 06113732261437685 1286531651437687 1430775 1431243 1431309 1431622 1431825 1431864 1432439 1432440 1433425 1433430 1433432 1433433 1434152 1435449 1435602 1435699 1435700 1436524 1436526 1436556 1437004 W123831741436428 1433424 1434969 14080361437684 1433431 1434993 1436525 1436527 1436528 1438068 1438130 1435702 1437055 1438069 1438131 1438455 X013918551437840 14277201440118 1434151 1434965 1435450 1435701 1435727 1435728 1436529 1436557 1436713 1438245 1438609 1438456 1438775 1438776 0398262151439704 1435603 1436712 1438872 1439145 V072510101439739 W0989675B1439738 1437581 1437877 1438664 1438873 1439144 1439379 1439380 1439387 1439582 U06811981440149 U06811981440151 V062154321440171 V092442911440169 1432436 1434964 1436365 1439944 1439945 1439946 W063349591440289 W073506871440084 1437451 1437582 1438953 1439581 1439947 U11852411440150 V062154311440165 V072329521440166 W093590691440288 W09919661440428 W103727321440287 1435852 1436366 1440186 1436367 1433438 1434153 1436555 1437050 1437580 1440654 1436364 1436711 1440187 1438954 1440655 1437057 1437876 1438297 1438454 1439325 1439512 1439513 1440239 1439323 1439750 1439752 1440238 1440575 1440576 1441171 1439514 1441170 1441535 1439753 1442404 01010095631444294 01112878341444296 0197579261444305 0197610691444306 0197842261444320 0285403251444307 0285523101444308 0285562241444309 02895142011444310 0297967521444312 0485730671444289 06113570991444291 0686252461444293 0798931781444290 1441359 1441718 1442049 03010220831444429 03113107711444440 03113335641444441 03113336361444442 0374147011444444 0397842251444450 0397913511444451 0398054701444453 07113789351444150 08011853901444155 1439324 1441410 1441716 1441961 1441962 1442050 1442313 1442407 1426645 1441492 1442201 1442405 1442406 1443050 1443053 1444193 1443262 1443489 1443490 U04705491444408 V112725371443806 W103767491443808 X064183591443810 03010819061444439 0363229471444443 0385562251444446 0385670021444447 0385730661444449 05113531101443811 1444194 1444342 W053277871443804 1440184 1440185 1443263 1432950 1444631 1444902 1440189 1444632 1445653 1445921 1445654 1446056 03113263491447082 04113343381447081 10012317451447124 1444903 1446966 W113767461447122 W113767531447123 W113857491447121 1447399 1447599 1446055 1446287 1446288 1446968 01112894471448087 1440127 1445938 1446020 1446939 1447397 1447600 W113767521447939 0586023501448096 1446176 1447786 1447787 1448190 V112725451447945 1446052 1447215 1448058 1448059 1448060 1448061 1448063 1448064 1448191 1448192 1448927 1448928 01112886231449440 05113539081449442 05113565991449443 0598437561449701 06011499591449438 08011897241449439 0986935661449700 1074719851449436 1074766231449711 11012435971449434 12012613881449435 1446021 1446053 1446177 1446938 1446940 V122874111449452 14154801449569 1444905 1447216 1448382 01010147751449539 02112969061449756 02113041371449534 03113144021449766 03113338081449531 0398310121449537 05113533911449792 05113652461449791 06011555561449765 07011838171450002 11460621449632 1299867951449762 14064991449764 1444904 1447213 1448381 1449428 1449429 U03667141449793 U06779811449794 U07764831449795 U07764931449798 U09852421449799 U10852431449797 U111161981449836 U111162101449819 U121437931449820 V062017171449800 V082154331449451 V082154331449801 W023009161449812 W023087681449805 W023087711449821 W033145651449822 W043212111449802 W043212131449807 W053212141449813 W063277911449823 W063349591449803 W063349661449824 W073349611449808 W073349621449814 W073441571449815 W073506901449816 W093590661449817 W09888841449809 W0989685111449818 W103590651449810 W103727301449804
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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