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 536 of 1191
FDA device recalls, page 536 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1886-2017Class IIStryker SmartLife Large Aseptic Housing (7126-120-000)Stryker Corp.HWE
Z-2583-2017Class IIXl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and...Zimmer GmbHLPH
Z-2582-2017Class IIXl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories...Zimmer GmbHLPH
Z-2581-2017Class IIPor fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories...Zimmer GmbHLPH
Z-2580-2017Class IIPor fullct fem st 18x200mm, Sterile,Zimmer GmbHLPH
Z-2579-2017Class IIPor fullct fem st 17x200mm, Sterile,Zimmer GmbHLPH
Z-2578-2017Class IIPor fullct fem st 16x200mm, Sterile,Zimmer GmbHLPH
Z-2577-2017Class IIPor fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, metal/polymer...Zimmer GmbHLPH
Z-2576-2017Class IISegmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer...Zimmer GmbHLZO
Z-2575-2017Class IISegmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and...Zimmer GmbHKRO
Z-2574-2017Class IISegmental fluted stem, 18x250mm bwd, Sterile,Zimmer GmbHKRO
Z-2573-2017Class IISegmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer...Zimmer GmbHKRO
Z-2572-2017Class IISegmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer...Zimmer GmbHKRO
Z-2571-2017Class IISegmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer...Zimmer GmbHKRO
Z-2570-2017Class IISegmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer...Zimmer GmbHKRO
Z-2569-2017Class IISegmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/polymer...Zimmer GmbHKRO
Z-2568-2017Class IISegmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/polymer...Zimmer GmbHKRO
Z-2567-2017Class IISegmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polymer...Zimmer GmbHKRO
Z-2566-2017Class IISegmental malefemale taper, 200mm, Sterile, Rod, fixation, intramedullary and...Zimmer GmbHKRO
Z-2565-2017Class IIFem IM Nail 14mmdx50cm right, Sterile, Rod, fixation, intramedullary and accessories...Zimmer GmbHHSB
Z-2564-2017Class IIFem IM Nail 14mmdx50cm left, Sterile, Rod, fixation, intramedullary and accessories...Zimmer GmbHHSB
Z-2563-2017Class IIFem IM Nail 14mmdx48cm right, Sterile, Rod, fixation, intramedullary and accessories...Zimmer GmbHHSB
Z-2562-2017Class IIFem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories...Zimmer GmbHHSB
Z-2561-2017Class IITibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories...Zimmer GmbHHSB
Z-2560-2017Class IIFem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific...Zimmer GmbHHSB
Z-2559-2017Class IIFem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific...Zimmer GmbHHSB
Z-2558-2017Class IIFem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific...Zimmer GmbHHSB
Z-2557-2017Class IIFem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific...Zimmer GmbHHSB
Z-2556-2017Class IIFem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific...Zimmer GmbHHSB
Z-2555-2017Class IIFem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific...Zimmer GmbHHSB
Z-2554-2017Class IIFem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific...Zimmer GmbHHSB
Z-2553-2017Class IIFem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific...Zimmer GmbHHSB
Z-2552-2017Class IIFem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific...Zimmer GmbHHSB
Z-2551-2017Class IIFem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessories- Specific...Zimmer GmbHHSB
Z-2550-2017Class IIFem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific...Zimmer GmbHHSB
Z-2549-2017Class IIPor fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories...Zimmer GmbHHSB
Z-1699-2017Class IIThe Stryker Visum LED Surgical Lighting system is intended to illuminate the operative...STRYKER Communications, Inc.FSY
Z-1760-2017Class IIHYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19, Rx ONLY, STERILE, Single...ConMed CorporationGEI
Z-1512-2017Class IIMammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast...Devicor Medical Products IncKNW
Z-1759-2017Class IISterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in...ConMed CorporationGEI
Z-1758-2017Class IISterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in...ConMed CorporationGEI
Z-1757-2017Class IISterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in...ConMed CorporationGEI
Z-1756-2017Class IISterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in...ConMed CorporationGEI
Z-2834-2018Class IILiebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems...Mallinckrodt, Inc.MQB
Z-2833-2018Class IILiebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology...Mallinckrodt, Inc.IXR
Z-1755-2017Class IIMEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and...Zimmer GmbHOLO
Z-1754-2017Class IIMEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation...Zimmer GmbHHAW
Z-1468-2017Class IIAxiom Artis fluoroscopic x-ray systemSiemens Medical Solutions USA, Inc.OWB
Z-1467-2017Class IIArtis Zee and Zeego fluoroscopic x-ray systemSiemens Medical Solutions USA, Inc.IZI
Z-1466-2017Class IIArtis Q and Q.Zen fluoroscopic x-ray systemSiemens Medical Solutions USA, Inc.OWB