Events

Retiro De Equipo (Recall) de Acumed SlideLoc Anatomic Radial Head System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Acumed LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    77115
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2197-2017
  • Fecha de inicio del evento
    2017-04-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-12-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154986
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Prosthesis, elbow, hemi-, radial, polymer - Product Code KWI
  • Causa
    The firm initiates a voluntary removal and discontinue marketing of slide-loc anatomic radial head system based on its performance in the market. the firm received product complaints regarding instrumentation performance, trial product design, and implant dissociations.
  • Acción
    The firm sent the Urgent Voluntary Medical Device Removal and Market Discontinuation letter to consignees on April 20, 2017. Consignees who would like to return product should contact Acumed Agent Inventory via email at Agentinventory@acumed.net to obtain Return Material Authorization (RMA) number. Consignees should return the completed survey via email to Returns@acumed.net. Customer can call 877-627-9957, option 4, or send email to customercomplaints@acumed.net if they have any adverse reactions or quality problem to report. Customers who have questions about this recall should contact Acumed Business Services via email at BusinessServices@acumed.net or call 877-627-9957, option 4.

Device

Acumed SlideLoc Anatomic Radial Head System
  • Modelo / Serial
    Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments. Below are Part numbers/ Description per set:  5001-0106N-S ARH Slide-Loc Standard Stem 6mm 5001-0107N-S ARH Slide-Loc Standard Stem 7mm 5001-0108N-S ARH Slide-Loc Standard Stem 8mm 5001-0109N-S ARH Slide-Loc Standard Stem 9mm 5001-0110N-S ARH Slide-Loc Standard Stem 10mm 5001-0111N-S ARH Slide-Loc Standard Stem 11mm 5001-0112N-S ARH Slide-Loc Standard Stem 12mm 5001-0218L-S ARH Slide-Loc Head 18mm, Left 5001-0218R-S ARH Slide-Loc Head 18mm, Right 5001-0220L-S ARH Slide-Loc Head 20mm, Left 5001-0220R-S ARH Slide-Loc Head 20mm, Right 5001-0222L-S ARH Slide-Loc Head 22mm, Left 5001-0222R-S ARH Slide-Loc Head 22mm, Right 5001-0224L-S ARH Slide-Loc Head 24mm, Left 5001-0224R-S ARH Slide-Loc Head 24mm, Right 5001-0226L-S ARH Slide-Loc Head 26mm, Left 5001-0226R-S ARH Slide-Loc Head 26mm, Right 5001-0228L-S ARH Slide-Loc Head 28mm, Left 5001-0228R-S ARH Slide-Loc Head 28mm, Right 5001-0301N-S ARH Slide-Loc Neck +1mm 5001-0303N-S ARH Slide-Loc Neck +3mm 5001-0305N-S ARH Slide-Loc Neck +5mm 5001-0406L-S ARH Slide-Loc Long Stem 6mm, Left 5001-0406R-S ARH Slide-Loc Long Stem 6mm, Right 5001-0408L-S ARH Slide-Loc Long Stem 8mm, Left 5001-0408R-S ARH Slide-Loc Long Stem 8mm, Right 5001-0410L-S ARH Slide-Loc Long Stem 10mm, Left 5001-0410R-S ARH Slide-Loc Long Stem 10mm, Right 5001-0412L-S ARH Slide-Loc Long Stem 12mm, Left 5001-0412R-S ARH Slide-Loc Long Stem 12mm, Right 5101-0106N ARH Slide-Loc Trial Standard Stem 6mm 5101-0107N ARH Slide-Loc Trial Standard Stem 7mm 5101-0108N ARH Slide-Loc Trial Standard Stem 8mm 5101-0109N ARH Slide-Loc Trial Standard Stem 9mm 5101-0110N ARH Slide-Loc Trial Standard Stem 10mm 5101-0111N ARH Slide-Loc Trial Standard Stem 11mm 5101-0218L ARH Slide-Loc Trial Head 18mm, Left 5101-0218R ARH Slide-Loc Trial Head 18mm, Right 5101-0220L ARH Slide-Loc Trial Head 20mm, Left 5101-0220R ARH Slide-Loc Trial Head 20mm, Right 5101-0222L ARH Slide-Loc Trial Head 22mm, Left 5101-0222R ARH Slide-Loc Trial Head 22mm, Right 5101-0224L ARH Slide-Loc Trial Head 24mm, Left 5101-0224R ARH Slide-Loc Trial Head 24mm, Right 5101-0226L ARH Slide-Loc Trial Head 26mm, Left 5101-0226R ARH Slide-Loc Trial Head 26mm, Right 5101-0228L ARH Slide-Loc Trial Head 28mm, Left 5101-0228R ARH Slide-Loc Trial Head 28mm, Right 5101-0301N ARH Slide-Loc Trial Neck +1mm 5101-0303N ARH Slide-Loc Trial Neck +3mm 5101-0305N ARH Slide-Loc Trial Neck +5mm 5101-0406L ARH Slide-Loc Trial Long Stem 6mm, LT 5101-0406R ARH Slide-Loc Trial Long Stem 6mm, RT 5101-0408L ARH Slide-Loc Trial Long Stem 8mm, LT 5101-0408R ARH Slide-Loc Trial Long Stem 8mm, RT 5101-0410L ARH Slide-Loc Trial Long Stem 10mm, LT 5101-0410R ARH Slide-Loc Trial Long Stem 10mm, RT 5101-0412L ARH Slide-Loc Trial Long Stem 12mm, LT 5101-0412R ARH Slide-Loc Trial Long Stem 12mm, RT 80-1357 ARH Slide-Loc Stem Inserter 80-1503 ARH Slide-Loc Impactor Block 80-1511 ARH Slide-Loc Head Assembly Tool 80-1514 ARH Slide-Loc Tray Base 80-1515 ARH Slide-Loc Tray Lid 80-1516 ARH Slide-Loc Instruments Level 1 80-1517 ARH Slide-Loc Instruments Level 2 80-1518 ARH Slide-Loc Trial Caddy 80-1519 ARH Slide-Loc Trial Caddy Lid 80-1581 ARH Slide-Loc Height Gauge +1mm 80-1583 ARH Slide-Loc Height Gauge +3mm 80-1585 ARH Slide-Loc Height Gauge +5mm 80-2004 ARH Slide-Loc Trial Head Handle 80-2538 ARH Slide-Loc Stem Clamp 80-2542 ARH Slide-Loc Locking Guide +1 mm 80-2543 ARH Slide-Loc Locking Guide +3 mm 80-2544 ARH Slide-Loc Locking Guide +5 mm  In addition to the sets, the firm also recalled 30 sterile implantable parts which sold separately from the sets. These Implants parts are provided sterile packaged. Below are Part numbers/ Description of each implant part:  5001-0106N-S ARH Slide-Loc Standard Stem 6mm 5001-0107N-S ARH Slide-Loc Standard Stem 7mm 5001-0108N-S ARH Slide-Loc Standard Stem 8mm 5001-0109N-S ARH Slide-Loc Standard Stem 9mm 5001-0110N-S ARH Slide-Loc Standard Stem 10mm 5001-0111N-S ARH Slide-Loc Standard Stem 11mm 5001-0112N-S ARH Slide-Loc Standard Stem 12mm 5001-0218L-S ARH Slide-Loc Head 18mm, Left 5001-0218R-S ARH Slide-Loc Head 18mm, Right 5001-0220L-S ARH Slide-Loc Head 20mm, Left 5001-0220R-S ARH Slide-Loc Head 20mm, Right 5001-0222L-S ARH Slide-Loc Head 22mm, Left 5001-0222R-S ARH Slide-Loc Head 22mm, Right 5001-0224L-S ARH Slide-Loc Head 24mm, Left 5001-0224R-S ARH Slide-Loc Head 24mm, Right 5001-0226L-S ARH Slide-Loc Head 26mm, Left 5001-0226R-S ARH Slide-Loc Head 26mm, Right 5001-0228L-S ARH Slide-Loc Head 28mm, Left 5001-0228R-S ARH Slide-Loc Head 28mm, Right 5001-0301N-S ARH Slide-Loc Neck +1mm 5001-0303N-S ARH Slide-Loc Neck +3mm 5001-0305N-S ARH Slide-Loc Neck +5mm 5001-0406L-S ARH Slide-Loc Long Stem 6mm, Left 5001-0406R-S ARH Slide-Loc Long Stem 6mm, Right 5001-0408L-S ARH Slide-Loc Long Stem 8mm, Left 5001-0408R-S ARH Slide-Loc Long Stem 8mm, Right 5001-0410L-S ARH Slide-Loc Long Stem 10mm, Left 5001-0410R-S ARH Slide-Loc Long Stem 10mm, Right 5001-0412L-S ARH Slide-Loc Long Stem 12mm, Left 5001-0412R-S ARH Slide-Loc Long Stem 12mm, Right   There are NO codes on each set.  There are 316 batch numbers of sterile implantable parts:  318837, 318838, 318839, 318845, 318846, 318847, 318848, 318850, 318851, 318852, 318853, 318854, 325925, 326011, 326167, 326380, 326381, 327677, 327678, 327820, 327821, 328328, 328329, 340828, 340983, 340984, 340985, 340986, 340987, 340988, 340989, 340990, 340991, 340992, 340993, 340994, 340995, 340996, 341228, 341462, 342818, 342819, 343520, 343521, 344017, 344018, 344568, 346243, 346463, 346871, 347064, 347065, 359410, 359411, 359413, 359414, 359415, 359416, 359417, 359418, 359419, 359420, 359421, 359422, 359467, 359468, 359508, 359546, 359547, 359674, 359695, 359696, 359697, 359771, 359772, 359773, 359873, 359874, 359875, 360073, 360074, 360270, 360271, 360272, 364290, 364291, 364343, 364344, 364345, 364861, 364942, 364943, 365364, 365365, 365595, 366132, 366133, 366383, 366384, 366881, 366882, 367098, 367099, 367100, 367154, 367155, 367183, 367184, 367185, 367186, 367187, 367188, 367189, 367190, 367191, 367192, 367585, 367586, 367835, 367836, 368412, 368413, 368415, 368477, 368478, 368479, 368480, 368481, 368482, 368483, 369799, 369800, 369802, 369805, 369807, 369808, 369809, 369810, 369811, 369812, 369813, 369814, 369815, 369819, 369821, 369824, 369943, 370708, 370709, 370885, 371112, 371113, 371114, 371115, 371252, 371253, 371276, 371277, 371278, 371279, 371345, 371346, 371347, 371515, 371516, 371683, 371684, 371685, 371853, 371854, 371855, 372038, 372040, 372041, 372042, 372045, 372048, 372593, 372594, 372595, 372652, 372653, 372654, 372655, 372656, 372657, 372658, 372659, 372660, 372661, 372662, 372718, 372821, 372822, 372974, 372975, 372976, 372977, 372978, 372979, 372980, 372981, 372982, 372983, 372984, 372985, 373002, 373007, 373008, 373010, 373012, 373593, 373594, 373595, 374627, 374638, 374838, 374921, 374922, 375164, 375165, 375280, 375394, 375395, 375406, 375407, 375644, 375645, 375779, 375780, 375970, 376069, 376145, 376146, 376147, 376506, 376793, 377180, 377181, 377183, 377184, 377185, 377186, 377187, 377191, 378626, 378653, 378654, 378655, 378846, 379027, 379582, 379585, 379586, 379587, 379588, 379589, 379591, 379592, 379593, 379594, 380192, 380451, 380562, 380563, 380688, 380689, 380690, 381003, 381004, 381239, 381240, 381889, 381890, 381894, 381896, 381897, 386301, 390811, 390812, 390813, 391361, 391363, 391364, 391366, 399030, 399046, 399047, 399483, 399484, 400446, 400447, 401367, 401368, 401369, 401562, 403716, 403717, 404189, 404190, 405629, 405731, 406406, 406534, 406535, 407518, 407581, 343520A, 344018A, 346243A, 368411A, 368412A, 368415A, 368478A, 373594A, and 373595A.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide distribution in the states of AK, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA and in Puerto Rico.
  • Descripción del producto
    The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. || The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitellum of the distal humerus. The modular heads and stems are single use implantable devices. || Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments.
  • Manufacturer
    Acumed LLC

Manufacturer

Acumed LLC
  • Dirección del fabricante
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9432
  • Empresa matriz del fabricante (2017)
    Acumed Llc
  • Source
    USFDA