National recall alert center immediate warning alert notification


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NRAC Issue #2088 February 10, 2016 25 Pages

NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION

THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION

THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, DC
SUMMARY PAGE
MEDICAL DEVICES
PRODUCT AccuPlace™ Needle Guides

MANUFACTURER Stryker Instruments

PAGE 14
PRODUCT ADVIA Centaur PSA Assay

MANUFACTURER Siemens Healthcare Diagnostics, Inc

PAGE 4
PRODUCT ADVIA Chemistry XPT Systems

MANUFACTURER Siemens Healthcare Diagnostics, Inc

PAGE 23
PRODUCT Allura Xper FD OR Table

MANUFACTURER Philips Electronics North America Corp

PAGE 23
PRODUCT Anesthesia Extension Tubes

MANUFACTURER Global Healthcare Inc

PAGE 24
PRODUCT API ZYM Bx2

MANUFACTURER BioMerieux SA

PAGE 7
PRODUCT AQURE System

MANUFACTURER Radiometer America Inc,

PAGE 23
PRODUCT Arctic Sun 5000 and Arctic Sun 2000

MANUFACTURER CR Bard, Inc

PAGE 12
PRODUCT Astral 100, 150

MANUFACTURER Resmed Corp

PAGE 5
PRODUCT CyberKnife Robotic Radiosurgery System Cosmetic Cover Package

MANUFACTURER Accuray Inc

PAGE 13
PRODUCT DVR ePAKs

MANUFACTURER Zimmer Biomet, Inc

PAGE 14
PRODUCT Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material

MANUFACTURER Biomet France SARL

PAGE 3
PRODUCT IMPLANT, TM, MTX

MANUFACTURER Zimmer Dental Inc

PAGE 6
PRODUCT Mavig Monitor Suspension System

MANUFACTURER GE Medical Systems, LLC

PAGE 11
PRODUCT Optima XR220amx, etc

MANUFACTURER GE Medical Systems, LLC

PAGE 8
PRODUCT Patient Transport Shuttle with Trendelenburg quick adjustment function

MANUFACTURER Trumpf Medical Systems, Inc

PAGE 13
PRODUCT Radiographic Cassette Holder or Wall Stand

MANUFACTURER Del Medical, Inc

PAGE 7
PRODUCT Round Burr, etc

MANUFACTURER Richard Wolf Medical Instruments Corp

PAGE 24
PRODUCT SIGMA HP MBT Non-Keel Punch Knee Instrument

MANUFACTURER DePuy Orthopaedics, Inc

PAGE 13
PRODUCT Synthes Small Electric Drive (SED)

MANUFACTURER The Anspach Effort, Inc

PAGE 13
PRODUCT TraumaDiagnost

MANUFACTURER Philips Electronics North America Corp

PAGE 23
PRODUCT Trilogy Devices

MANUFACTURER Philips Healthcare

PAGE 15
PRODUCT Trios Surgical Table Base

MANUFACTURER Mizuho OSI

PAGE 14
PRODUCT Virage OCT Spinal Fixation System Closure Caps

MANUFACTURER Zimmer Spine

PAGE 15
PRODUCT Zimmer UNI High Flex Precoat Femoral Implants

MANUFACTURER Smith & Nephew, Inc

PAGE 15
PHARMACEUTICALS
PRODUCT Atorvastatin Calcium

MANUFACTURER Golden State Medical Supply Inc

PAGE 24
PRODUCT PARICALCITOL Capsules

MANUFACTURER Teva Pharmaceuticals USA, Inc

PAGE 24
PRODUCT Sodium Chloride Irrigation

MANUFACTURER Baxter Healthcare Corp

PAGE 25
PRODUCT TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder)

MANUFACTURER AstraZeneca

PAGE 25
-----------------------------------------------------------------------------------------------------------------------------------------------


PRODUCT Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material

RECALL NUMBER Z-0788-2016

CODE Item numbers: ROX05, ROX10, ROX20, ROXLG20; lot numbers:

S016303

S016304

S0163056

S0163059

S0171051

S017105R

S0171098

T0001122

T0001133

T0001136

T0001141

T0001147

T0025073

T0034084

T0045150

T0045157

T0052108

T0064164

T0064168

T0064175

T0096191

T0104217

T0104238

T0114238

T0122226

T0122238

T0134261

T0134269

T0142245

T0142248

T0162294

T0183280

T0192311

T0192316

T0205297

T0214319

T0224329

T0224333

T0224338

T0224346

T0224357

T0234357

T0245006

T0245009

T0254015

T0266030

T0273037

T0273051

T0281043

T0281065

T0281078

T0291099

T0291106

T0291118

T0291125

T0291134

U0013175

U0025142

U0025170

U0035175

U0055155

U0055170

U0084189

U0084209

U0092202

U0092237

U0102265

U0114279

U0124272

U0132289

U0132307

U0132316

U0141251

U0141254

U0141265

U0153300

U0171316

U0181349

U0193328

U0193349

U0201005

U0201019

U0201337

U0201349

U0213019

U0213040

U0242047

U0253061

U0253068

U0253075

U0253082

U0253089

U0253138

U0261131

U0261148

U0261159

V0021138

V0021176

V0034194

V0044201

V0044208

V0044239

V0051267

V0082187

S0171056

S0171065

S0171108

T0001119

T0001122

T0001133

T0001136

T0001141

T0001147

T0025073

T0025098

T0034084

T0045150

T0045157

T0052108

T0064168

T0074175

T0074179

T0084189

T0096191

T0104217

T0114238

T0134261

T0142248

T0142254

T0162294

T0183280

T0192311

T0192316

T0205297

T0214319

T0234357

T0245006

T0245020

T0254015

T0254051

T0266030

T0273037

T0281043

T0281062

T0281065

T0281071

T0291078

T0291125

T0291170

T0304134

T0304170

U0035142

U0035155

U0035237

U0073170

U0084189

U0092202

U0102251

U0114279

U0114286

U0114307

U0124265

U0124272

U0141254

U0153300

U0171316

U0193328

U0201005

U0201337

U0201349

U0213026

U0223026

U0234054

U0234061

U0242040

U0253082

U0253089

U0261124

V0021138

V0021148

V0021168

V0044194

V0044208

V0082187

T0001119

T0001133

T0001150

T0025098

T0052108

T0064164

T0074157

T0074175

T0074189

T0096191

T0104217

T0134261

T0183280

T0192311

T0205297

T0224338

T0224346

T0234357

T0245006

T0245009

T0254015

T0254024

T0266030

T0273037

T0273051

T0281043

T0281065

T0281078

T0281093

T0291099

T0291106

T0304125

T0304155

U0013142

U0013170

U0055142

U0092189

U0092202

U0092254

U0114279

U0124265

U0132307

U0141251

U0153300

U0193328

U0201349

U0234061

U0253082

U0261106

U0261138

V0021148

V0034187

V0034194

V0044208

T0002136

T0002141

T0002150

T0002157

T0002164

T0035065

T0035073

T0035084

T0035098

MANUFACTURED & RECALLED BY Biomet France SARL, France

QUANTITY 145,116 units

DISTRIBUTION Nationwide and internationally

REASON Cytotoxicity tests were not passed at 36 months. Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury.
-----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT ADVIA Centaur PSA Assay

RECALL NUMBER Z-0754-2016

CODE Catalog number 02676506, 06574155; SMN 10310292, 10310293; lot numbers:

00825265 0063041420300300825265160424

12970266 0063041420300312970266160721

12971266 0063041420299012971266160721

13429266 0063041420299013429266160721

14158266 0063041420300314158266160721

19651266 0063041420299019651266160721

23016266 0063041420300323016266160721

27278266 0063041420299027278266160721

28881266 0063041420300328881266160721

35089266 0063041420299035089266160721

39805268 0063041420299039805268160922

40776268 0063041420300340776268160922

50851268 0063041420299050851268160922

54448263 0063041420299054448263160223

54637263 0063041420300354637263160223

55171263 0063041420299055171263160223

55304263 0063041420300355304263160223

56171264 0063041420299056171264160327

56249264 0063041420300356249264160327

76727264 0063041420300376727264160327

77560264 0063041420299077560264160327

92415265 0063041420299092415265160424

92416265 0063041420300392416265160424

96996265 0063041420299096996265160424

99151265 0063041420300399151265160424

MANUFACTURED & RECALLED BY Siemens Healthcare Diagnostics, Inc, East Walpole, MA

QUANTITY 55,754 kits

DISTRIBUTION Nationwide

REASON PSA assay is not meeting the High Does Hook Effect expectation in the Instructions for Use (IFU).
-----------------------------------------------------------------------------------------------------------------------------------------------
PRODUCT Astral 100, 150

RECALL NUMBER Z-0746-2016

CODE Model: 27001, 27003; Code:

22151602599

22151165418

22151602685

22151445692

22151602619

22151165422

22151515931

22151311475

22151326784

22151325468

22151555669

22151483525

22151468531

22151326769

22151397101

22151445637

22151602618

22151445665

22141311864

22151134267

22151483829

22151445648

22151135060

22151165451

22151468443

22151310751

22151445729

22151608456

22151310738

22151163312

22151483614

22151503642

22151326732

22151445642

22151602661

22151326740

22151468423

22141446603

22151310692

22151397049

22151608387

22151468501

22151602609

22151311468

22151515897

22151602606

22141308828

22151311357

22151326830

22151602464

22141269879

22151483575

22151468439

22151135063

22151165506

22151602463

22151602450

22151134277

22151555588

22151515918

22151298925

22151614505

22151009058

22151134301

22151602513

22151483507

22151483838

22151073639

22151310689

22151134268

22151311315

22151311355

22151326713

22151468425

22141322647

22151468435

22151326825

22141311871

22151515945

22151468451

22151397124

22151572261

22151468446

22151165444

22141297685

22151165469

22151349228

22141647466

22141647471

22151349232

22151326811

22151375663

22151326736

22151009031

22151503649

22151445672

22151483530

22151602426

22151602696

22151602642

22151602589

22151165455

22151349230

22151602436

22151445673

22151468489

22151165486

22151134271

22151326717

22151445781

22151349229

22151445733

22151503605

22151326792

22151397106

22151483578

22151399534

22151468473

22151602592

22151397144

22151310737

22151468482

22151468507

22151249721

22151298923

22151325465

22151483610

22151503631

22151310732

22151311505

22151572265

22151375703

22151503640

22151311498

22151298940

22151608435

22141647463

22151614499

22151602651

22151311336

22151022635

22151298950

22151602490

22151326774

22151514267

22151311321

22151572227

22151602497

22151399533

22151602505

22151483594

22151445754

22151310734

22151399565

22151445734

22151224492

22151515904

22151445747

22151503636

22151614522

22151237239

22151608481

22151311345

22151445641

22151468399

22151445677

22151614504

22151608468

22151161888

22151602593

22151165383

22151165527

22151483514

22151608389

22151503623

22151608375

22151445766

22151468478

22151608421

22151483833

22151602673

22151483521

22151514302

22151445732

22151608386

22151310690

22141647462

22151468453

22151031714

22141322529

22141311842

22151165371

22151031738

22141322514

22141308878

22141620655

22151483608

22151009057

22141322511

22141322516

22151165402

22141311897

22141336263

22151468533

22141308874

22151572266

22151666671

22141420659

22151375695

22151691843

22151572245

22151572241

22151779327

22141336257
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