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-2144-2015 | Class II | ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surface Trial snaps... | Depuy Orthopaedics Inc. | MBH | |
| Z-2143-2015 | Class II | ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation... | Depuy Orthopaedics Inc. | MBH | |
| Z-2142-2015 | Class II | ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation... | Depuy Orthopaedics Inc. | MBH | |
| Z-2141-2015 | Class II | ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface... | Depuy Orthopaedics Inc. | MBH | |
| Z-2140-2015 | Class II | ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: The Tibial... | Depuy Orthopaedics Inc. | MBH | |
| Z-2139-2015 | Class II | ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface... | Depuy Orthopaedics Inc. | MBH | |
| Z-2138-2015 | Class II | ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface... | Depuy Orthopaedics Inc. | MBH | |
| Z-2137-2015 | Class II | ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation... | Depuy Orthopaedics Inc. | MBH | |
| Z-1956-2015 | Class II | JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray... | Bolder Surgical, LLC | GDW | |
| Z-1955-2015 | Class II | JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in a tray... | Bolder Surgical, LLC | GDW | |
| Z-1972-2015 | Class II | SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and... | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-2202-2015 | Class II | ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem... | Abbott Medical | JJE | |
| Z-2460-2015 | Class II | Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes | Aso LLC | KGX | |
| Z-2091-2015 | Class II | Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure... | Synthes (USA) Products LLC | HSB | |
| Z-2097-2015 | Class II | Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego... | Maquet Cardiovascular Us Sales, LLC | FQO | |
| Z-2084-2015 | Class II | NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system... | Northern Digital Inc. | HAW | |
| Z-1991-2015 | Class II | Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element... | Evident Scientific MIS, Inc. | RBS | |
| Z-2455-2015 | Class II | Offset Femoral Alignment Guide 4mm x 6; Product Code: KS 67024 Product Usage: The... | Omni Life Science, Inc. | FZX | |
| Z-2454-2015 | Class II | Offset Femoral Alignment Guide, 2mm x 6; Product Code: KS 67022 Product Usage: The... | Omni Life Science, Inc. | FZX | |
| Z-1989-2015 | Class II | Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product... | Alliance Partners, LLC | KWQ | |
| Z-1988-2015 | Class II | Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The... | Allergan | MRD | |
| Z-2328-2015 | Class II | Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is... | Philips North America LLC | MKJ | |
| Z-2155-2015 | Class II | Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile... | Cochlear Americas | MCM | |
| Z-2538-2015 | Class II | Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray... | Panoramic Rental Corp. | EHD | |
| Z-2151-2015 | Class II | THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical... | Gardner Denver Thomas Inc | JCX | |
| Z-2150-2015 | Class II | THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 Product Usage: medical... | Gardner Denver Thomas Inc | JCX | |
| Z-2149-2015 | Class II | THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical... | Gardner Denver Thomas Inc | JCX | |
| Z-1845-2015 | Class II | Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is... | Volcano Corporation | DQX | |
| Z-1844-2015 | Class II | Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is... | Volcano Corporation | OBJ | |
| Z-1934-2015 | Class II | SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-1826-2015 | Class II | Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile... | Merit Medical Systems, Inc. | DRE | |
| Z-2046-2015 | Class II | A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a... | Zimmer GmbH | HRS | |
| Z-1933-2015 | Class II | SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-2445-2015 | Class II | APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354... | Omni Life Science, Inc. | LPH | |
| Z-2058-2015 | Class II | A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw | Zimmer GmbH | HRS | |
| Z-2747-2015 | Class II | Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers... | Smith & Nephew, Inc. | NXT | |
| Z-2746-2015 | Class II | Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers... | Smith & Nephew, Inc. | NXT | |
| Z-2745-2015 | Class II | Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF... | Smith & Nephew, Inc. | NXT | |
| Z-2372-2015 | Class I | Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect... | Elite Biomedical Solutions LLC | FRN | |
| Z-2371-2015 | Class I | Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect... | Elite Biomedical Solutions LLC | FRN | |
| Z-2065-2015 | Class II | Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford... | Zimmer GmbH | HWT | |
| Z-1945-2015 | Class II | Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw... | Zimmer GmbH | HWC | |
| Z-1944-2015 | Class II | Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for... | Zimmer GmbH | HWC | |
| Z-2051-2015 | Class II | TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX... | Synthes GmbH | JDS | |
| Z-2064-2015 | Class II | Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex... | Omni Life Science, Inc. | LZO | |
| Z-1831-2015 | Class II | SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are... | Stryker Corp. | GEI | |
| Z-2130-2015 | Class II | Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard"... | Revvity Health Sciences, Inc. | JJJ | |
| Z-2129-2015 | Class II | Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The... | Revvity Health Sciences, Inc. | JJJ | |
| Z-2128-2015 | Class II | Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The... | Revvity Health Sciences, Inc. | JJJ | |
| Z-2127-2015 | Class II | Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The... | Revvity Health Sciences, Inc. | JJJ |