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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-2868-2017 | Class II | ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of... | Zimmer GmbH | HAW | |
| Z-0720-2017 | Class II | Radiation Therapy Treatment Planning System Product Usage: RayStation is a software... | RaySearch Laboratories AB (publ) | MUJ | |
| Z-0584-2017 | Class III | RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U | Stryker Corp. | GXD | |
| Z-0393-2017 | Class II | NRG Transseptal Needle and NRG RF Transseptal Kit. Model/Catalogue Numbers... | Baylis Medical Co., Inc. | DXF | |
| Z-0781-2017 | Class II | Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous... | Nuvectra Corporation | LGW | |
| Z-0379-2017 | Class II | ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the... | Abbott Medical | KHP | |
| Z-0117-2017 | Class I | Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP... | Abbott Medical | NIK | |
| Z-0116-2017 | Class I | Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40... | Abbott Medical | LWS | |
| Z-0115-2017 | Class I | Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40... | Abbott Medical | LWS | |
| Z-0589-2017 | Class II | Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA... | Siemens Healthcare Diagnostics Inc. | JJY | |
| Z-2032-2017 | Class II | 20.2cm Heavy Duty Long Heavy Short Attachment | The Anspach Effort, Inc. | BWN | |
| Z-2031-2017 | Class II | Sagittal MICRO-SAW | The Anspach Effort, Inc. | BWN | |
| Z-2030-2017 | Class II | 5.0cm Heavy Duty Short Attachment | The Anspach Effort, Inc. | BWN | |
| Z-2029-2017 | Class II | 5.0cm Short Attachment | The Anspach Effort, Inc. | BWN | |
| Z-2028-2017 | Class II | Small Attachment, J-Latch | The Anspach Effort, Inc. | BWN | |
| Z-2027-2017 | Class II | Small Attachment, Jacobs Chuck | The Anspach Effort, Inc. | BWN | |
| Z-2026-2017 | Class II | Reciprocating MICRO SAW | The Anspach Effort, Inc. | BWN | |
| Z-2025-2017 | Class II | 7.5cm QD Angle Attachment | The Anspach Effort, Inc. | BWN | |
| Z-2024-2017 | Class II | 8cm QD Angle Attachment | The Anspach Effort, Inc. | BWN | |
| Z-2023-2017 | Class II | 14cm QD Angle Attachment | The Anspach Effort, Inc. | BWN | |
| Z-2022-2017 | Class II | 14cm QD Angle Attachment Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2021-2017 | Class II | 10.5cm QD Angle Attachment Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2020-2017 | Class II | 11cm QD Angle Attachment Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2019-2017 | Class II | Oscillating MICRO-SAW Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2018-2017 | Class II | 90 degree Contra Angle Attachment Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2017-2017 | Class II | 45 degree Contra Angle Attachment Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2016-2017 | Class II | Otologic Curved Micro Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2015-2017 | Class II | Sagittal Saw Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2014-2017 | Class II | 16cm Minimally Invasive Attachment Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2013-2017 | Class II | 8.0CM Heavy Duty Medium Attachment Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2012-2017 | Class II | 8.0cm Medium Attachment Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2011-2017 | Class II | Minimal Access Straight Driver Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2010-2017 | Class II | Minimal Access Attachment, BLACK MAX Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2009-2017 | Class II | Minimal Access Attachment Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2008-2017 | Class II | Bearing Sleeve, 19CM Straight Taper Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2007-2017 | Class II | Bearing Sleeve, 15CM Straight Taper Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2006-2017 | Class II | Bearing Sleeve, 15CM Straight Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2005-2017 | Class II | Bearing Sleeve, 15CM Curved Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2004-2017 | Class II | Bearing Sleeve, 10CM Straight Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2003-2017 | Class II | Bearing Sleeve, 10CM Curved Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2002-2017 | Class II | 10.5cm Long Attachment Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2001-2017 | Class II | 12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-2000-2017 | Class II | 10.5cm Long Attachment, Non-Tapered End Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-1999-2017 | Class II | 11.0cm Long Attachment Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-1998-2017 | Class II | IMRI SHORT HD ATTACHMENT Product Usage: Pneumatic system | The Anspach Effort, Inc. | HBE | |
| Z-1997-2017 | Class II | IMRI SHORT ATTACHMENT Product Usage: Pneumatic system | The Anspach Effort, Inc. | HBE | |
| Z-1996-2017 | Class II | IMRI CRANI-A ATTACHMENT Product Usage: Pneumatic system | The Anspach Effort, Inc. | HBE | |
| Z-1995-2017 | Class II | Keyless Driver Product Usage: Pneumatic system | The Anspach Effort, Inc. | BWN | |
| Z-1994-2017 | Class II | Chuck Driver System | The Anspach Effort, Inc. | BWN | |
| Z-1993-2017 | Class II | Compact Speed Reducer, 60:1 Black Max | The Anspach Effort, Inc. | BWN |