The Acumed Slide-Loc Anatomic Radial Head System is recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product

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…

Recalling firm

Acumed LLC

Quantity

13076 parts total (8373 units of parts/instruments and 4703 units of implantable parts)

Distribution

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.

Recall date

June 7, 2017

Classification

Class II

Status

Terminated

Agency

FDA (device)