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-3177-2017 | Class II | ECT Internal Fracture Fixation Drill Bits 4.5 mm Diameter (.177 Inch), Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3176-2017 | Class II | ECT Internal Fracture Fixation Drill 4.5 mm Diameter (.177 Inch), Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3175-2017 | Class II | Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonsterile... | Zimmer GmbH | HWE | |
| Z-3174-2017 | Class II | Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonsterile... | Zimmer GmbH | HWE | |
| Z-3173-2017 | Class II | ECT Internal Fracture Fixation Drill Bits 3.5 mm Diameter (.138 Inch), Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3172-2017 | Class II | ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3171-2017 | Class II | ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3170-2017 | Class II | ECT Internal Fracture Fixation Drill 3.2 mm Diameter (.126 Inch), Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3169-2017 | Class II | ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch), Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3168-2017 | Class II | ECT Internal Fracture Fixation Drill 2.7 mm Diameter (.106 Inch), Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3167-2017 | Class II | ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3166-2017 | Class II | ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3165-2017 | Class II | ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch) , Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3164-2017 | Class II | ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3163-2017 | Class II | ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3162-2017 | Class II | ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3161-2017 | Class II | ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106... | Zimmer GmbH | HWE | |
| Z-3160-2017 | Class II | M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm Item Number/EDI 00225503550... | Zimmer GmbH | HWE | |
| Z-3159-2017 | Class II | M/DN, Intramedullary Fixation Distal Drill Pilot Tip 3.7 mm Diameter Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3158-2017 | Class II | M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3157-2017 | Class II | NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 195 mm... | Zimmer GmbH | HWE | |
| Z-3156-2017 | Class II | ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm(8 Inch)... | Zimmer GmbH | HWE | |
| Z-3155-2017 | Class II | M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3154-2017 | Class II | NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 3.5 mm Diameter 195 mm... | Zimmer GmbH | HWE | |
| Z-3153-2017 | Class II | Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 00480606011... | Zimmer GmbH | HWE | |
| Z-3152-2017 | Class II | Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 00480507015... | Zimmer GmbH | HWE | |
| Z-3151-2017 | Class II | Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443... | Zimmer GmbH | HWE | |
| Z-3150-2017 | Class II | ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item... | Zimmer GmbH | HWE | |
| Z-3149-2017 | Class II | Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7... | Zimmer GmbH | HWE | |
| Z-3148-2017 | Class II | ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-3147-2017 | Class II | M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32, Item... | Zimmer GmbH | HWE | |
| Z-3146-2017 | Class II | Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/EDI... | Zimmer GmbH | HWE | |
| Z-0196-2018 | Class II | TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase... | Becton Dickinson & Co | JSO | |
| Z-0168-2018 | Class II | Syngo.plaza, Picture Archiving and Communications System(PACS), Model... | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-2740-2017 | Class II | PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF... | Flowonix Medical Inc | LKK | |
| Z-2627-2017 | Class III | DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear... | Svar Life Science AB | LKJ | |
| Z-3145-2017 | Class II | Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item... | Zimmer GmbH | HWE | |
| Z-3144-2017 | Class II | Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter... | Zimmer GmbH | KWT | |
| Z-2532-2017 | Class II | Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F... | Creganna Medical Ireland Limited | DYB | |
| Z-2531-2017 | Class II | Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F... | Creganna Medical Ireland Limited | DYB | |
| Z-2530-2017 | Class II | Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F... | Creganna Medical Ireland Limited | DYB | |
| Z-2529-2017 | Class II | Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F... | Creganna Medical Ireland Limited | DYB | |
| Z-2867-2017 | Class II | MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for... | Sentinel CH SpA | JFY | |
| Z-2632-2017 | Class II | 3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure... | 3M Company | KZD | |
| Z-2690-2017 | Class II | Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when... | Siemens Healthcare Diagnostics Inc. | PER | |
| Z-2689-2017 | Class II | Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a... | Siemens Healthcare Diagnostics Inc. | PER | |
| Z-2644-2017 | Class II | Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation... | Exactech, Inc. | LXH | |
| Z-2701-2017 | Class II | The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and... | Natus Medical Incorporated | MEC | |
| Z-3045-2017 | Class II | Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT... | Neusoft Medical Systems Co., Ltd. | JAK | |
| Z-3044-2017 | Class II | Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e... | Neusoft Medical Systems Co., Ltd. | JAK |