510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,544 records, page 604 of 1191
FDA device recalls, page 604 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0850-2016Class IIMetasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory...Zimmer GmbHKWA
Z-0849-2016Class IIVERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8...Zimmer GmbHLPH
Z-0848-2016Class IIVERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous...Zimmer GmbHLPH
Z-0847-2016Class IIVERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous...Zimmer GmbHLPH
Z-0846-2016Class IIVERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous...Zimmer GmbHLPH
Z-0845-2016Class IIBipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or...Zimmer GmbHKWY
Z-0844-2016Class IICPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous...Zimmer GmbHJDI
Z-0843-2016Class IICPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous...Zimmer GmbHJDI
Z-0842-2016Class IIPRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained...Zimmer GmbHNJL
Z-0841-2016Class IINexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee...Zimmer GmbHNJL
Z-0840-2016Class IICR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous...Zimmer GmbHMBH
Z-0839-2016Class IINKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial...Zimmer GmbHJWH
Z-0838-2016Class IICR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee...Zimmer GmbHJWH
Z-0837-2016Class IIGender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained...Zimmer GmbHKRR
Z-0836-2016Class IIZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained...Zimmer GmbHHSX
Z-0835-2016Class IINexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen...Zimmer GmbHJWH
Z-0834-2016Class IINexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis...Zimmer GmbHJWH
Z-0833-2016Class IINexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee...Zimmer GmbHJWH
Z-0832-2016Class IINexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee...Zimmer GmbHJWH
Z-0831-2016Class IINexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous...Zimmer GmbHJWH
Z-0830-2016Class IILPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented...Zimmer GmbHJWH
Z-0859-2016Class IISpecify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord...Medtronic NeuromodulationLGW
Z-0805-2016Class IIEclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number...Varian Medical Systems, Inc.MUJ
Z-0793-2016Class IISmith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument...Smith & Nephew, Inc.NBH
Z-0743-2016Class IIABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the...Horiba Instruments IncorporatedKNK
Z-0742-2016Class IIABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the...Horiba Instruments IncorporatedCDT
Z-0741-2016Class IIABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in...Horiba Instruments IncorporatedKHP
Z-0740-2016Class IIABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in...Horiba Instruments IncorporatedCFR
Z-0739-2016Class IIABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the...Horiba Instruments IncorporatedCGX
Z-0738-2016Class IIThe ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for...Horiba Instruments IncorporatedCHH
Z-1099-2016Class IIProduct 1 consists of all product under , product code: JWH and same usage: Item...Zimmer Manufacturing B.V.HWC
Z-1028-2016Class IIKopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle...Cook IncorporatedMIJ
Z-0787-2016Class IISIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in...Depuy Orthopaedics Inc.LRY
Z-0797-2016Class IIFirebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for...Orthofix SRLHXC
Z-0756-2016Class IIAPI ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for...bioMerieux, Inc.LIB
Z-0757-2016Class IIOlympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument...OLYMPUS Corporation of the AmericasFDT
Z-0745-2016Class IIDS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy...Philips North America LLCIYE
Z-1363-2016Class IIMedix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator.Natus Medical IncorporatedFMZ
Z-1887-2016Class IHeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only...HeartWare, Inc.DSQ
Z-1264-2016Class IIClear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device...Anholt Technologies Inc.IYE
Z-1045-2016Class IIMaquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to...Maquet Cardiovascular Us Sales, LLCFQO
Z-1496-2016Class IICatalog Number: 900998 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform...Customed, IncOHM
Z-1495-2016Class IICatalog Number: 900997 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical...Customed, IncOKV
Z-1494-2016Class IICatalog Number: 900996 LAPAROTOMY SURGICAL PACK Used by medical staff to perform...Customed, IncLRO
Z-1493-2016Class IICatalog Number: 900982 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform...Customed, IncOJH
Z-1492-2016Class IICatalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform...Customed, IncLRO
Z-1491-2016Class IICatalog Number: 900944 CATARACT SURGICAL PACK Used by medical staff to perform surgical...Customed, IncOJK
Z-1490-2016Class IICatalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to perform...Customed, IncOHM
Z-1489-2016Class IICatalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical staff to...Customed, IncOEQ
Z-1488-2016Class IICatalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform...Customed, IncLRO