FDAFDA · Alimentos y medicamentos·N.º oficial Z-0165-2015
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
Publicado el 12 de noviembre de 2014 · Inicio del retiro: 6 de octubre de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by itself when the power source is connected.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Zimmer Surgical Inc
- Distribuidor
- US Nationwide Distribution in the states of: AK, AL,AR, AZ,CA,CO,CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA,ME, MI, MN, MO, NC, NE, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY.
- Lote
- 89-8507-400-00 - UNIVERSAL Modular Electric/Battery Double Trigger Handpiece 89-8507-400-10 - UNIVERSAL Modular Electric/Battery Single Trigger Handpiece 222805 222806 222807 222808 222809 222810 222811 222812 222813 222814 222945 222946 222947 222948 222949 222950 222951 222952 222953 222955 222956 223077 223078 223079 223080 223081 223082 223083 223084 223085 223086 223199 223200 223201 223202 223203 223204 223205 223206 223207 223208 223209 223210 223401 223403 223404 223405 223406 223407 223408 223409 223410 223411 223730 223731 223732 223733 223734 223735 223736 223737 223738 223739 223804 224187 224188 224189 224190 224191 224192 224193 224194 224195 224196 224197 224198 224199 224200 224201 224202 224203 224204 224205 224206 224207 224208 224209 224210 224393 224394 224395 224396 224397 224398 224399 224400 224402 224625 224626 224627 224628 224629 224630 224631 224632 224633 224634 224635 224636 224637 224638 224639 224640 224641 224642 224643 224644 224645 224646 224647 224648 224815 224816 224819 224825 224997 224998 224999 225000 225001 225002 225003 225004 225005 225006 225007 225124 225125 225126 225127 225128 225129 225130 225131 225132 225133 225134 225135 225297 225298 225299 225301 225302 225303 225304 225305 225306 225307 225418 225419 225420 225421 225422 225423 225424 225425 225426 225427 225428 225429 225530 225531 225532 225533 225534 225535 225536 225537 225538 225539 225540 225554 225555 225556 225557 225558 225559 225560 225561 225563 225564 225565 225566 225567 225568 225569 225570 225571 225572 225573 225574 225575 225576 225577 226491 226492 226493 226494 226495 226496 226497 226498 226499 226500 226501 226502 226504 226511 226512 226513 226514 226515 226516 226517 226518 226519 226520 226521 226522 226523 226524 226525 226526 226527 226528 226529 226530 226531 226532 226533 226534 226535 226536 226537 226538 226539 226540 226541 226542 226543 226544 226545 226546 226547 226548 226549 226550 227582 227590 227594 227811 227820 227821 227822 227823 227824 227825 227826 227827 227828 227829 228165 228166 228167 228168 228169 228170 228171 228172 228173 228175 228177 228178 228179 228180 228181 228182 228183 228184 228185 228186 228187 228188 228370 228371 228372 228373 228374 228375 228376 228377 228378 228381 228382 228384 228387 228389 228390 228391 228392 228393 228394 228395 228396 228397 228399 228400 228401 228402 228403 228405 228406 228407 228419 228420 228421 228422 228423 228424 228425 228426 228427 228428 228462 228463 228464 228465 228467 228468 228469 228470 228471 228472 228473 228474 228475 228476 228477 228478 228479 228480 228481 228482 228900 228901 228902 228943 228944 228945 228946 228947 228948 228949 228950 228951 228952 228953 228954 228955 228956 228957 228958 228959 228960 228961 228962 228963 228964 228965 228966 228967 228969 228977 228979 228981 228982 228990 228994 228995 228996 228997 228998 229003 229008 229011 229012 229013 229014 229015 229016 229017 229018 229019 229020 229021 229022 229023 229024 229026 229027 229029 229030 229031 229032 229683 229684 229685 229686 229687 229688 229689 229690 229691 229692 229694 229699 229701 229929 229930 229933 229934 229935 229964 229965 229966 229967 229968 229969 229970 229971 229972 229973 229974 229975 229976 229977 229978 229980 229981 229982 229983 229984 229985 229986 229987 229988 229989 229990 229991 229992 229993 230099 230100 230101 230102 230103 230104 230105 230106 230109 230111 230112 230113 230114 230117 230139 230140 230141 230142 230143 23
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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