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1,784 recalls
High RiskFDA
Biomet 3i, Llc
Conical EP Pick-Up Coping (Hexed) Dental implants
Medical Implants·1,648,273 affected·Nov 25, 2015
High RiskFDA
Boston Scientific Corporation
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114...
Medical Implants·900 affected·Nov 25, 2015
High RiskFDA
Zimmer, Inc.
Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Perso...
Medical Implants·156 affected·Nov 24, 2015
RecallFDA
Collagen Matrix Inc
ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive tr...
Medical Implants·200 affected·Nov 17, 2015
High RiskFDA
Biomet 3i, Llc
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
Medical Implants·686 affected·Nov 16, 2015
High RiskFDA
Aesculap, Inc.
Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the ...
Medical Implants·37 affected·Nov 10, 2015
High RiskFDA
Aesculap, Inc.
Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended for use during the implantati...
Medical Implants·13 affected·Nov 10, 2015
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, ST...
Medical Implants·20 affected·Nov 9, 2015
High RiskFDA
Medtronic Inc.
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Medical Implants·96,787 affected·Nov 9, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ra...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, includin...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interve...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging applications, including diagnostic a...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including dia...
Medical Implants·13,297 affected·Nov 3, 2015
CriticalFDA
St Jude Medical Cardiac Rhythm Management Division
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for...
Medical Implants·447 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by traine...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Philips Electronics North America Corporation
UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neuro...
Medical Implants·13,297 affected·Nov 3, 2015
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm ...
Medical Implants·478 affected·Oct 28, 2015
High RiskFDA
Merz North America, Inc.
PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implan...
Medical Implants·9,439 affected·Oct 26, 2015
High RiskFDA
Otto Bock Healthcare Gmbh
iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankl...
Medical Implants·273 affected·Oct 23, 2015
High RiskFDA
Covidien Llc
Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic...
Medical Implants·160 affected·Oct 14, 2015
High RiskFDA
Covidien Llc
Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palind...
Medical Implants·280 affected·Oct 14, 2015
High RiskFDA
Covidien Llc
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Num...
Medical Implants·10 affected·Oct 14, 2015
High RiskFDA
Covidien Llc
Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145046C T...
Medical Implants·150 affected·Oct 14, 2015
High RiskFDA
Synthes (usa) Products Llc
Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
Medical Implants·20,494 affected·Oct 8, 2015
High RiskFDA
Philips Electronics North America Corporation
Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in ca...
Medical Implants·196 affected·Oct 1, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon...
Medical Implants·3,444 affected·Sep 29, 2015
High RiskFDA
Exactech, Inc.
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit f...
Medical Implants·8 affected·Sep 23, 2015
High RiskFDA
Biomet 3i, Llc
BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended f...
Medical Implants·30,111 affected·Sep 21, 2015
High RiskFDA
Biomet 3i, Llc
BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as...
Medical Implants·30,111 affected·Sep 21, 2015
High RiskFDA
Smiths Medical Asd, Inc.
PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are...
Medical Implants·130 affected·Sep 14, 2015
High RiskFDA
Encore Medical, Lp
Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to...
Medical Implants·277 affected·Sep 14, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
Medical Implants·201 affected·Sep 8, 2015
High RiskFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a per...
Medical Implants·23 affected·Sep 4, 2015
High RiskFDA
Conformis, Inc.
ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGH...
Medical Implants·110 affected·Aug 31, 2015
High RiskFDA
Limacorporate S.p.a
SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; ...
Medical Implants·93 affected·Aug 14, 2015
High RiskFDA
Otto Bock Healthcare Product
Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be us...
Medical Implants·1 affected·Aug 12, 2015
High RiskFDA
Zimmer, Inc.
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to f...
Medical Implants·18 affected·Aug 11, 2015
High RiskFDA
Biomet, Inc.
Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.
Medical Implants·5 affected·Jul 28, 2015
High RiskFDA
Trilliant Surgical Ltd.
Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are compone...
Medical Implants·71 affected·Jul 20, 2015
High RiskFDA
Trilliant Surgical Ltd.
2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE...
Medical Implants·102 affected·Jul 20, 2015
High RiskFDA
Otto Bock Healthcare Gmbh
Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthe...
Medical Implants·518 affected·Jul 16, 2015
High RiskFDA
Customed, Inc
ORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical procedures and patient care procedures such as wound healin...
Medical Implants·639 affected·Jul 10, 2015
High RiskFDA
Customed, Inc
IMPLANTE DE ORTHOPEDIA 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, ...
Medical Implants·81 affected·Jul 10, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
Medical Implants·16 affected·Jun 25, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar he...
Medical Implants·16,992 affected·Jun 24, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.
Medical Implants·16,992 affected·Jun 24, 2015