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 615 of 1191
FDA device recalls, page 615 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2435-2016Class IIPreformance 15 degrees pre-angled post Dental implantsZimVie US Corp LLCNHA
Z-2126-2016Class IIBattery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort...The Anspach Effort, Inc.MOQ
Z-1588-2016Class IIMAKOplasty Hip Array Kit Laminate 150230Mako Surgical Corp.OLO
Z-2434-2016Class IIPick-Up Impression Coping Dental implantsZimVie US Corp LLCDZE
Z-2433-2016Class IILocator Replacement Males 4pk Dental implantsZimVie US Corp LLCDZE
Z-2432-2016Class IILocator Replacement Housing Kit Dental implantsZimVie US Corp LLCDZE
Z-2431-2016Class IILocator Replacement Housing Dental implantsZimVie US Corp LLCDZE
Z-2430-2016Class IILocator Light Retention Replacement Males 4pk Dental implantsZimVie US Corp LLCDZE
Z-2429-2016Class IILocator Extra Light Retention Males 4pk Dental implantsZimVie US Corp LLCDZE
Z-2428-2016Class IILocator Extra Light Angled Replacement Males 4pk Dental implantsZimVie US Corp LLCDZE
Z-2427-2016Class IILocator Extended Range Males 4pk Dental implantsZimVie US Corp LLCDZE
Z-2426-2016Class IIO-Ring Abutment 4.1mm(D) x 6mm(H) Item: OSO60 Dental implantsZimVie US Corp LLCDZE
Z-2425-2016Class IIO-Ring Abutment 4.1mm(D) x 4mm(H) Item: OSO40 Dental implantsZimVie US Corp LLCDZE
Z-2424-2016Class IIO-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implantsZimVie US Corp LLCDZE
Z-2423-2016Class IILDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implantsZimVie US Corp LLCNHA
Z-2422-2016Class IILDA Screw SBL 3mm(D) Item: SCRSBL1 Dental implantsZimVie US Corp LLCNHA
Z-2421-2016Class IIGold-Tite Square Uniscrew Item: UNISG Dental implantsZimVie US Corp LLCNHA
Z-2420-2016Class IIGold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implantsZimVie US Corp LLCNHA
Z-2419-2016Class IIGingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G Dental...ZimVie US Corp LLCNHA
Z-2418-2016Class IICertain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implantsZimVie US Corp LLCNHA
Z-2417-2016Class IICertain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implantsZimVie US Corp LLCNHA
Z-2416-2016Class IICertain Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 Dental implantsZimVie US Corp LLCNHA
Z-2415-2016Class IICertain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implantsZimVie US Corp LLCNHA
Z-2414-2016Class IICertain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 Dental implantsZimVie US Corp LLCNHA
Z-2413-2016Class IICertain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental implantsZimVie US Corp LLCNHA
Z-2412-2016Class IICertain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G Dental implantsZimVie US Corp LLCNHA
Z-2411-2016Class IICertain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G Dental implantsZimVie US Corp LLCNHA
Z-2410-2016Class IICertain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental...ZimVie US Corp LLCNHA
Z-2409-2016Class IICertain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item...ZimVie US Corp LLCNHA
Z-2408-2016Class IICertain EP Healing Abutment 5mm(D) x 6mm(P) x 4mm(H) Item: IWTH564 Dental implantsZimVie US Corp LLCNHA
Z-2407-2016Class IICertain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implantsZimVie US Corp LLCNHA
Z-2406-2016Class IICertain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implantsZimVie US Corp LLCNHA
Z-0791-2016Class IIReuseable rotary blade/abrader, product number 899751514. The oval burr frontally hooded...Richard Wolf Medical Instruments Corp.HRX
Z-0790-2016Class IIReuseable rotary blade/abrader, product number 899751504. The oval burr laterally hooded...Richard Wolf Medical Instruments Corp.HRX
Z-0789-2016Class IIReuseable rotary blade/abrader, product number 899751305. The round burr is an...Richard Wolf Medical Instruments Corp.HRX
Z-0686-2016Class IIWilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation...Abeon Medical CorporationKNT
Z-0685-2016Class IITLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in...Abeon Medical CorporationFFO
Z-0684-2016Class IITLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO...Abeon Medical CorporationFFO
Z-0565-2016Class IIRenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number...RenovoRx, Inc.MJN
Z-0600-2016Class IIActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of...KCI USA, Inc.OMP
Z-0588-2016Class IIBoston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105...Boston Scientific CorporationDQY
Z-0858-2016Class IIPhilips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient...Philips North America LLCMHX
Z-0857-2016Class IIPhilips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With...Philips North America LLCMHX
Z-0856-2016Class IIPhilips Healthcare IntelliVue Info Center iX, A.0 866023Philips North America LLCMHX
Z-0469-2016Class IIHook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic...Instratek, IncorporatedHRX
Z-0447-2016Class IIMOSAIQ Oncology Information System. Used to manage workflows for treatment planning and...Elekta LimitedIYE
Z-0411-2016Class IIPersona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee...Zimmer GmbHLXH
Z-0410-2016Class IIPersona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee...Zimmer GmbHLXH
Z-2121-2016Class IIThe ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin...ZYTO Technologies, Inc.GZO
Z-2120-2016Class IIThe ZYTO Tower is the input device to program the software with various virtual items.ZYTO Technologies, Inc.GZO