CLASS II Device recall · Reported 7 Jun 2017 · FDA Enforcement Report

Slide-Loc Anatomic Radial Head System is intended recalled by Acumed

Acumed is recalling The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with, distributed nationwide in the US. The recall was initiated on 20 Apr 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesEach 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.

Quantity recalled13076 parts total (8373 units of parts/instruments and 4703 units of implantable parts)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2197-2017
FDA event ID: 77115
Recalling firm: Acumed, Hillsboro, OR
Classification: Class II
Status: Terminated
Recall initiated: 20 Apr 2017
FDA classified: 31 May 2017
Reported: 7 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

20 Apr 2017	Recall initiated by company
31 May 2017	Classified by FDA	+41 days
7 Jun 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alaska Arizona California Colorado Connecticut Florida Hawaii Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Michigan Minnesota Missouri Montana North Carolina Nebraska

Questions about this recall

Is Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic recalled?

Yes. Acumed recalled Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic on 20 Apr 2017. The recall is Class II and its status is Terminated. Recall number Z-2197-2017.

Why was it recalled?

Which lots 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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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