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-0435-2018 | Class II | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM | Zimmer GmbH | HSB | |
| Z-0434-2018 | Class II | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM | Zimmer GmbH | HSB | |
| Z-0433-2018 | Class II | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM | Zimmer GmbH | HSB | |
| Z-0432-2018 | Class II | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM | Zimmer GmbH | HSB | |
| Z-0431-2018 | Class II | Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM | Zimmer GmbH | HSB | |
| Z-0430-2018 | Class II | Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM | Zimmer GmbH | HSB | |
| Z-0429-2018 | Class II | Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM | Zimmer GmbH | HSB | |
| Z-0428-2018 | Class II | Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM | Zimmer GmbH | HSB | |
| Z-0427-2018 | Class II | Affixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM | Zimmer GmbH | HSB | |
| Z-0426-2018 | Class II | Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM | Zimmer GmbH | HSB | |
| Z-0425-2018 | Class II | Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM | Zimmer GmbH | HSB | |
| Z-0424-2018 | Class II | Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM | Zimmer GmbH | HSB | |
| Z-0423-2018 | Class II | Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM | Zimmer GmbH | HSB | |
| Z-0422-2018 | Class II | Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM | Zimmer GmbH | HSB | |
| Z-0421-2018 | Class II | Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM | Zimmer GmbH | HSB | |
| Z-0420-2018 | Class II | Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM | Zimmer GmbH | HSB | |
| Z-3131-2017 | Class II | Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic... | Mako Surgical Corp. | OLO | |
| Z-3130-2017 | Class II | Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive... | Mako Surgical Corp. | OLO | |
| Z-3106-2017 | Class I | Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire... | Spectranetics Corp. | MJN | |
| Z-3103-2017 | Class II | MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1... | Terumo Cardiovascular Systems Corporation | MOF | |
| Z-0977-2018 | Class II | OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case... | ZOLL Medical Corporation | MKJ | |
| Z-0662-2018 | Class II | Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed... | FUJIFILM Healthcare Americas Corporation | MUE | |
| Z-0661-2018 | Class II | ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE... | FUJIFILM Healthcare Americas Corporation | MUE | |
| Z-0660-2018 | Class II | Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems... | FUJIFILM Healthcare Americas Corporation | MUE | |
| Z-0659-2018 | Class II | Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR... | FUJIFILM Healthcare Americas Corporation | MUE | |
| Z-3102-2017 | Class II | MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF... | Encore Medical, LP | HTO | |
| Z-3218-2017 | Class II | Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile... | Ultradent Products Inc. | EKN | |
| Z-3217-2017 | Class II | Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, sterile... | Ultradent Products Inc. | EKN | |
| Z-3216-2017 | Class II | Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile... | Ultradent Products Inc. | EKN | |
| Z-3215-2017 | Class II | Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile... | Ultradent Products Inc. | EKN | |
| Z-3214-2017 | Class II | Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile... | Ultradent Products Inc. | EKN | |
| Z-1337-2018 | Class II | Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system | Gyrus ACMI, Inc. | EQJ | |
| Z-0597-2018 | Class II | Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior... | Orthopediatrics Corp | OSH | |
| Z-0668-2018 | Class III | Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559 | Ivoclar Vivadent, Inc. | EBF | |
| Z-0667-2018 | Class III | Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503 | Ivoclar Vivadent, Inc. | EBF | |
| Z-0666-2018 | Class III | Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502 | Ivoclar Vivadent, Inc. | EBF | |
| Z-0665-2018 | Class III | Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 | Ivoclar Vivadent, Inc. | EBF | |
| Z-0046-2018 | Class II | Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample... | Siemens Healthcare Diagnostics Inc. | JJE | |
| Z-0895-2018 | Class II | Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 | Instrumentation Laboratory Co. | GJS | |
| Z-0779-2019 | Class II | Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The... | Haemonetics Corporation | CAC | |
| Z-0778-2019 | Class II | Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The... | Haemonetics Corporation | CAC | |
| Z-0728-2018 | Class III | JANUS & JANUS G3 Automated Workstation is an automated programmable liquid handling... | Revvity Health Sciences, Inc. | JQW | |
| Z-0021-2018 | Class I | The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire... | OriGen Biomedical, Inc. | DWF | |
| Z-3127-2017 | Class II | Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile... | Orthofix SRL | NKB | |
| Z-2883-2018 | Class II | GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026... | Smith & Nephew, Inc. | JWH | |
| Z-0722-2018 | Class II | Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6... | Zimmer GmbH | LPH | |
| Z-0721-2018 | Class II | Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No... | Zimmer GmbH | KRO | |
| Z-3107-2017 | Class II | Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are... | Medtronic, Inc. | LRO | |
| Z-2658-2018 | Class II | 120" (305 cm) 10 Drop Primary Set w/2 MicroClave, Hand Pump, Remv 2 Gang 4-Way Stopcock... | Abbott Medical | FMG | |
| Z-2657-2018 | Class II | 116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave, 2 Ext... | Abbott Medical | FMG |