{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Hillsboro",
      "address_1": "5885 NW Cornelius Pass Rd",
      "reason_for_recall": "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.",
      "address_2": "",
      "product_quantity": "13076 parts total (8373 units of parts/instruments and 4703 units of implantable parts)",
      "code_info": "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.",
      "center_classification_date": "20170531",
      "distribution_pattern": "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.",
      "state": "OR",
      "product_description": "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.",
      "report_date": "20170607",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Acumed LLC",
      "recall_number": "Z-2197-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "77115",
      "termination_date": "20171201",
      "more_code_info": "",
      "recall_initiation_date": "20170420",
      "postal_code": "97124-9432",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}