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Medical device recalls reported in 2016

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ReportedRecallClassProductFirm
2016-08-31Z-2651-2016Class IIMedtronicMedtronic Inc., Cardiac Rhythm and Heart Failure
2016-08-31Z-2652-2016Class IIBrilliance 64 CT Model number 728231 Product Usage: Computed…Philips Medical Systems (Cleveland) Inc
2016-08-31Z-2653-2016Class IIBrilliance CT Big Bore OncologyPhilips Medical Systems (Cleveland) Inc
2016-08-31Z-2654-2016Class IIBrilliance BigBore Radiology CT Model number 728244 Product Usage:…Philips Medical Systems (Cleveland) Inc
2016-08-31Z-2655-2016Class IIBrilliance 16Philips Medical Systems (Cleveland) Inc
2016-08-31Z-2656-2016Class IIBrilliance CT 16 PowerPhilips Medical Systems (Cleveland) Inc
2016-08-31Z-2657-2016Class IIIngenuity CorePhilips Medical Systems (Cleveland) Inc
2016-08-31Z-2658-2016Class IIIngenuity Core128Philips Medical Systems (Cleveland) Inc
2016-08-31Z-2659-2016Class IINovaPACS versions 8Novarad Corporation
2016-08-31Z-2660-2016Class IIInfinite F50 instrumentTecan US, Inc.
2016-08-31Z-2661-2016Class IISUNRISE instrumentTecan US, Inc.
2016-08-31Z-2662-2016Class IITecan Infinite 200Tecan US, Inc.
2016-08-31Z-2663-2016Class IIInfinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional…Tecan US, Inc.
2016-08-31Z-2664-2016Class IITecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional…Tecan US, Inc.
2016-08-31Z-2665-2016Class IITecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a…Tecan US, Inc.
2016-08-31Z-2666-2016Class IIHydroflex ELISA The HYDROFLEX is a plate washer for 96-well…Tecan US, Inc.
2016-08-31Z-2667-2016Class IIAlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system…Vision RT Ltd
2016-08-31Z-2668-2016Class IITrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy…Vision RT Ltd
2016-08-24Z-2403-2016Class IOraQuick Ebola Rapid Antigen TestOraSure Technologies, Inc.
2016-08-24Z-2406-2016Class IICertain EP Healing Abutment 5mmBiomet 3i, LLC
2016-08-24Z-2407-2016Class IICertain EP Healing Abutment 5mmBiomet 3i, LLC
2016-08-24Z-2408-2016Class IICertain EP Healing Abutment 5mmBiomet 3i, LLC
2016-08-24Z-2409-2016Class IICertain Gingihue TM 15 degree Angled Post 3Biomet 3i, LLC
2016-08-24Z-2410-2016Class IICertain Gingihue 15 degree Angled Post 4Biomet 3i, LLC
2016-08-24Z-2411-2016Class IICertain Gingihue Post 5mmBiomet 3i, LLC
2016-08-24Z-2412-2016Class IICertain Gingihue Post 3Biomet 3i, LLC
2016-08-24Z-2413-2016Class IICertain Gingihue Post 4Biomet 3i, LLC
2016-08-24Z-2414-2016Class IICertain Pick-Up Coping 4Biomet 3i, LLC
2016-08-24Z-2415-2016Class IICertain Pick-Up Coping 4Biomet 3i, LLC
2016-08-24Z-2416-2016Class IICertain Pick-Up Coping 5mmBiomet 3i, LLC
2016-08-24Z-2417-2016Class IICertain Straight Healing Abutment 4Biomet 3i, LLC
2016-08-24Z-2418-2016Class IICertain Straight Pick-Up Coping 5Biomet 3i, LLC
2016-08-24Z-2419-2016Class IIGingihue 15 degrees Pre-Angled Post 4mmBiomet 3i, LLC
2016-08-24Z-2420-2016Class IIGold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implantsBiomet 3i, LLC
2016-08-24Z-2421-2016Class IIGold-Tite Square Uniscrew Item: UNISG Dental implantsBiomet 3i, LLC
2016-08-24Z-2422-2016Class IILDA Screw SBL 3mmBiomet 3i, LLC
2016-08-24Z-2423-2016Class IILDA Screw SBL 4mmBiomet 3i, LLC
2016-08-24Z-2424-2016Class IIO-Ring Abutment 4Biomet 3i, LLC
2016-08-24Z-2425-2016Class IIO-Ring Abutment 4Biomet 3i, LLC
2016-08-24Z-2426-2016Class IIO-Ring Abutment 4Biomet 3i, LLC
2016-08-24Z-2427-2016Class IILocator Extended Range Males 4pk Dental implantsBiomet 3i, LLC
2016-08-24Z-2428-2016Class IILocator Extra Light Angled Replacement Males 4pk Dental implantsBiomet 3i, LLC
2016-08-24Z-2429-2016Class IILocator Extra Light Retention Males 4pk Dental implantsBiomet 3i, LLC
2016-08-24Z-2430-2016Class IILocator Light Retention Replacement Males 4pk Dental implantsBiomet 3i, LLC
2016-08-24Z-2431-2016Class IILocator Replacement Housing Dental implantsBiomet 3i, LLC
2016-08-24Z-2432-2016Class IILocator Replacement Housing Kit Dental implantsBiomet 3i, LLC
2016-08-24Z-2433-2016Class IILocator Replacement Males 4pk Dental implantsBiomet 3i, LLC
2016-08-24Z-2434-2016Class IIPick-Up Impression Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2435-2016Class IIPreformance 15 degrees pre-angled post Dental implantsBiomet 3i, LLC
2016-08-24Z-2436-2016Class IIPreformance Post Dental implantsBiomet 3i, LLC
2016-08-24Z-2437-2016Class IIPreformance Temporary Cylinder Dental implantsBiomet 3i, LLC
2016-08-24Z-2438-2016Class IIPrep-tite Cap Dental implantsBiomet 3i, LLC
2016-08-24Z-2439-2016Class IIPrep-Tite Post Dental implantsBiomet 3i, LLC
2016-08-24Z-2440-2016Class IIProvide Impression Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2441-2016Class IIProvide Protection Cap Dental implantsBiomet 3i, LLC
2016-08-24Z-2442-2016Class IIQuickbridge TM Cap Dental implantsBiomet 3i, LLC
2016-08-24Z-2443-2016Class IIStandard Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2444-2016Class IIStandard Abutment Pick -Up Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2445-2016Class IIStandard Abutment Temporary Screw Dental implantsBiomet 3i, LLC
2016-08-24Z-2446-2016Class IIStandard Abutment Transfer Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2447-2016Class IITemporary Healing Retention Cylinder Dental implantsBiomet 3i, LLC
2016-08-24Z-2448-2016Class IITemporary Hexed Cylinder Dental implantsBiomet 3i, LLC
2016-08-24Z-2449-2016Class IITemporary Non-Hexed Cylinder Dental implantsBiomet 3i, LLC
2016-08-24Z-2450-2016Class IITitanium Hexed Uniscrew Dental implantsBiomet 3i, LLC
2016-08-24Z-2451-2016Class IITitanium Square Uniscrew Dental implantsBiomet 3i, LLC
2016-08-24Z-2452-2016Class IIConical EP Healing Cap Dental implantsBiomet 3i, LLC
2016-08-24Z-2453-2016Class IIConical EP Pick-Up CopingBiomet 3i, LLC
2016-08-24Z-2454-2016Class IIConical EP Pick-Up CopingBiomet 3i, LLC
2016-08-24Z-2455-2016Class IIConical EP Twist Lock TM Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2456-2016Class IIConical Healing Cap Dental implantsBiomet 3i, LLC
2016-08-24Z-2457-2016Class IICover Screw Dental implantsBiomet 3i, LLC
2016-08-24Z-2458-2016Class IICover ScrewBiomet 3i, LLC
2016-08-24Z-2459-2016Class IIDAL-RO HousingBiomet 3i, LLC
2016-08-24Z-2460-2016Class IIDAL-RO Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2461-2016Class IIDAL-RO Threaded Female Dental implantsBiomet 3i, LLC
2016-08-24Z-2462-2016Class IIDrill Stop Dental implantsBiomet 3i, LLC
2016-08-24Z-2463-2016Class IIEP Healing Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2464-2016Class IIGingihue 15 Degree Pre-Angled Post Dental implantsBiomet 3i, LLC
2016-08-24Z-2465-2016Class IIGingihue Post Dental implantsBiomet 3i, LLC
2016-08-24Z-2466-2016Class IIGold Slotted Screw Dental implantsBiomet 3i, LLC
2016-08-24Z-2467-2016Class IIGold -Tite Hexed Retaining Screw Dental implantsBiomet 3i, LLC
2016-08-24Z-2468-2016Class IIHealing Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2469-2016Class IIImplant Cover Screw Dental implantsBiomet 3i, LLC
2016-08-24Z-2470-2016Class IIImplant EP Pick-Up Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2471-2016Class IIImplant EP Twist Lock TM Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2472-2016Class IIImplant Twist Lock TM Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2473-2016Class IIIndex Coping Surgical Dental implantsBiomet 3i, LLC
2016-08-24Z-2474-2016Class IIIOL Abutment and Screw Dental implantsBiomet 3i, LLC
2016-08-24Z-2475-2016Class IIIOL Distal Extension Dental implantsBiomet 3i, LLC
2016-08-24Z-2476-2016Class IIIOL Healing Cap Dental implantsBiomet 3i, LLC
2016-08-24Z-2477-2016Class IIIOL Pick-Up Impression Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2478-2016Class IIIOL Titanium Temporary Cylinder Dental implantsBiomet 3i, LLC
2016-08-24Z-2479-2016Class IIIOL Transfer Impression Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2480-2016Class IILocator Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2481-2016Class IILocator Abutment Impression Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2482-2016Class IICertain Hex Try-in ScrewBiomet 3i, LLC
2016-08-24Z-2483-2016Class IICertain Implant Cover Screw Dental implantsBiomet 3i, LLC
2016-08-24Z-2484-2016Class IICertain Implant EP Twist Lock TM Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2485-2016Class IICertain Implant Straight Cover Screw Dental implantsBiomet 3i, LLC
2016-08-24Z-2486-2016Class IICertain IOL Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2487-2016Class IICertain Locator Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2488-2016Class IICertain Micromini Flat Implant Cover Screw Dental implantsBiomet 3i, LLC
2016-08-24Z-2489-2016Class IICertain Non-Hexed Implant Pick-up Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2490-2016Class IICertain Pick-up Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2491-2016Class IICertain Preformance 15 degrees Pre-Angled Post Dental implantsBiomet 3i, LLC
2016-08-24Z-2492-2016Class IICertain Preformance Post Dental implantsBiomet 3i, LLC
2016-08-24Z-2493-2016Class IICertain Preformance Temporary Cylinder Dental implantsBiomet 3i, LLC
2016-08-24Z-2494-2016Class IICertain Provide Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2495-2016Class IICertain Standard Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2496-2016Class IICertain Straight Healing Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2497-2016Class IICertain Straight Pick Up Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2498-2016Class IICertain Temporary Hexed Cylinder Dental implantsBiomet 3i, LLC
2016-08-24Z-2499-2016Class IICertain Temporary Non-Hexed Cylinder Dental implantsBiomet 3i, LLC
2016-08-24Z-2500-2016Class IICertain Titanium Large Hexed Screw Dental implantsBiomet 3i, LLC
2016-08-24Z-2501-2016Class IICertain Twist Lock TM Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2502-2016Class IICertain Twist Lock TM Straight Transfer Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2503-2016Class IICertain Twist Lock TM Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2504-2016Class IIConical 17 degree Angled Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2505-2016Class IIConical 25 degree Angled Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2506-2016Class IIConical Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2507-2016Class IIConical Abutment Gold Standard ZR TM Dental implantsBiomet 3i, LLC
2016-08-24Z-2508-2016Class IIConical Abutment Pick-up Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2509-2016Class IICertain EP Healing Abutment 4Biomet 3i, LLC
2016-08-24Z-2510-2016Class IIBellatek Encode Healing Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2511-2016Class IICertain EP Twist Lock TM Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2512-2016Class IICertain Bellatek Encode Healing Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2513-2016Class IICertain Conical 17 degree Angled Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2514-2016Class IICertain Conical 25 degree Angled Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2515-2016Class IICertain Conical Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2516-2016Class IICertain Cover Screw Dental implantsBiomet 3i, LLC
2016-08-24Z-2517-2016Class IICertain EP Healing Abutment Dental implantsBiomet 3i, LLC
2016-08-24Z-2518-2016Class IICertain EP Pick-Up Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2519-2016Class IICertain EP Twist Lock TM Coping Dental implantsBiomet 3i, LLC
2016-08-24Z-2520-2016Class IICertain Flat Implant Cover Screw Dental implantsBiomet 3i, LLC
2016-08-24Z-2521-2016Class IICertain Gingihue TM 15 degree Angled Post Dental implantsBiomet 3i, LLC
2016-08-24Z-2522-2016Class IICertain Gingihue 15 degree Pre- Angled Post Dental implantsBiomet 3i, LLC
2016-08-24Z-2523-2016Class IICertain Gingihue Post Dental implantsBiomet 3i, LLC
2016-08-24Z-2524-2016Class IICertain Gingihue 15 degree Angled Post Dental implantsBiomet 3i, LLC
2016-08-24Z-2526-2016Class IIAB Sciex API 3200MD" LC/MS/MS SystemAb Sciex
2016-08-24Z-2527-2016Class IIAB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vitro…Ab Sciex
2016-08-24Z-2528-2016Class IIAB SCIEX Triple Quad 4500MD LC/MS/MS SystemAb Sciex
2016-08-24Z-2529-2016Class IIAB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro…Ab Sciex
2016-08-24Z-2530-2016Class IIPerioscopy Sheath: Part number: 1008Danville Materials, Inc.
2016-08-24Z-2531-2016Class IIiConnect Access used with Merge PACS software provides medical…Merge Healthcare, Inc.
2016-08-24Z-2532-2016Class IIiConnect Access used with Ortho PACS software provides medical…Merge Healthcare, Inc.
2016-08-24Z-2533-2016Class IISynovis VASCU-GUARD Peripheral Vascular Patch in the following sizes…Baxter Healthcare Corp.
2016-08-24Z-2534-2016Class IIStraumann Bone Level ImplantStraumann Manufacturing, Inc.
2016-08-24Z-2535-2016Class IIStraumann Bone Level ImplantStraumann Manufacturing, Inc.
2016-08-24Z-2536-2016Class IIStryker AutoPlex SystemStryker Instruments Div. of Stryker Corporation
2016-08-24Z-2538-2016Class IIWeck EFx Classic Fascial Closure SystemTeleflex Medical
2016-08-24Z-2539-2016Class IITRYX Antibacterial Envelope Rx Only Product Usage: Indicated for…TYRX Inc.
2016-08-24Z-2540-2016Class IITRYX Absorbable Antibacterial Envelope Product Usage: Indicated for…TYRX Inc.
2016-08-24Z-2541-2016Class IITRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated…TYRX Inc.
2016-08-24Z-2542-2016Class IIXario 100 Diagnostic Ultrasound SystemToshiba American Medical Systems Inc
2016-08-24Z-2543-2016Class II1LeMaitre Vascular, Inc.
2016-08-24Z-2544-2016Class II1LeMaitre Vascular, Inc.
2016-08-24Z-2545-2016Class II1LeMaitre Vascular, Inc.
2016-08-24Z-2546-2016Class IIMedtronic EnVeo R Delivery Catheter SystemMedtronic Cardiovascular Surgery-the Heart Valve Division
2016-08-24Z-2547-2016Class IIBard TruGuide Disposable Coaxial Biopsy Needle  Mixed Product Part…Bard Peripheral Vascular Inc
2016-08-24Z-2548-2016Class IIXpert MRSA Catalog GXMRSA-120Cepheid
2016-08-24Z-2549-2016Class IIMindray DS USA IncMindray DS USA, Inc. dba Mindray North America
2016-08-24Z-2550-2016Class IIQuattro Air FFM MED  AMERResmed Corporation
2016-08-24Z-2551-2016Class IIMerge Unity Z3D softwareMerge Healthcare, Inc.
2016-08-24Z-2552-2016Class IIReShape Integrated Dual Balloon SystemReshape Medical Inc
2016-08-24Z-2553-2016Class IIMETS SMILES Total Knee ReplacementStanmore Implants Worldwide Ltd.
2016-08-24Z-2554-2016Class IIValleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item…Medtronic
2016-08-24Z-2555-2016Class IIValleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item…Medtronic
2016-08-24Z-2556-2016Class IIValleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" Item…Medtronic
2016-08-24Z-2557-2016Class IIValleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes…Medtronic
2016-08-24Z-2558-2016Class IIValleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item…Medtronic
2016-08-24Z-2559-2016Class IIValleylab Laparoscopic Argon Sharp Needle Electrode 28CM Item Code:…Medtronic
2016-08-24Z-2560-2016Class IIValleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm Item…Medtronic
2016-08-24Z-2561-2016Class IIValleylab Laparoscopic Straight Spatula Electrode 36C Item Code:…Medtronic
2016-08-24Z-2562-2016Class IIValleylab Laparoscopic Curved Spatula Electrode 36CM Item Code:…Medtronic
2016-08-24Z-2563-2016Class IIValleylab Laparoscopic Curved Spatula Electrode 45CM Item Code:…Medtronic
2016-08-24Z-2564-2016Class IIValleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236…Medtronic
2016-08-24Z-2565-2016Class IIValleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336…Medtronic
2016-08-24Z-2566-2016Class IIValleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345…Medtronic
2016-08-24Z-2567-2016Class IIValleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436…Medtronic
2016-08-24Z-2568-2016Class IIValleylab Laparoscopic Straight Spatula Electrode 28CM Item Code:…Medtronic
2016-08-24Z-2569-2016Class IIValleylab Laparoscopic Curved Spatula Electrode 28CM Item Code:…Medtronic
2016-08-24Z-2570-2016Class IIValleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item…Medtronic
2016-08-24Z-2571-2016Class IIValleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228…Medtronic
2016-08-24Z-2572-2016Class IIValleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item…Medtronic
2016-08-24Z-2573-2016Class IIValleylab Laparoscopic Wire L-Hook Electrode 28CM Item Code: E278328…Medtronic
2016-08-24Z-2574-2016Class IIValleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code:…Medtronic
2016-08-24Z-2575-2016Class IIValleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code:…Medtronic
2016-08-24Z-2576-2016Class IIValleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428…Medtronic
2016-08-24Z-2577-2016Class IIValleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code:…Medtronic
2016-08-24Z-2578-2016Class IIValleylab Laparoscopic Cylindrical Tip Electrode 28CM Item Code:…Medtronic
2016-08-24Z-2579-2016Class IIGE Centricity PACS WorkstationGE Healthcare It
2016-08-24Z-2580-2016Class IIIVITROS Immunodiagnostic Products TSH Reagent PackORTHO-CLINICAL DIAGNOSTICS
2016-08-24Z-2581-2016Class IITI Single Vector Distractor Body with Right Foot/20mmSynthes (USA) Products LLC
2016-08-24Z-2582-2016Class IITI Single Vector Distractor Body with Left Foot/20mmSynthes (USA) Products LLC
2016-08-24Z-2583-2016Class IITI Single Vector Distractor Body with Right Foot/30mmSynthes (USA) Products LLC
2016-08-24Z-2584-2016Class IITI Single Vector Distractor Body with Left Foot/30mmSynthes (USA) Products LLC
2016-08-24Z-2585-2016Class IITI Single Vector Distractor Proximal Foot/RightSynthes (USA) Products LLC
2016-08-24Z-2586-2016Class IITI Single Vector Distractor Proximal Foot/LeftSynthes (USA) Products LLC
2016-08-24Z-2587-2016Class IIOPTICAL BIOMETER AL-Scan: Software Version: 1Nidek Inc
2016-08-24Z-2588-2016Class IIPROFEMURMicroPort Orthopedics Inc.

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