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-2261-2010 | REF 70-0077-103, 3mm ARTHRO-KNIFE SHEATHED KNIFE, SERRATED, STRAIGHT, 2-SIDED, STERILE... | Linvatec Corporation | HRX | ||
| Z-2260-2010 | REF 70-0076-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, CRESCENT, STRAIGHT, STERILE, Rx ONLY... | Linvatec Corporation | HRX | ||
| Z-2259-2010 | REF 70-0075-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, MINI-MENISCUS, STRAIGHT, STERILE, Rx... | Linvatec Corporation | HRX | ||
| Z-2258-2010 | REF 70-0074-103, 3mm ARTHRO-KNIFE SHEATHED KNIFE, ROSETTE, SERRATED, STRAIGHT, STERILE... | Linvatec Corporation | HRX | ||
| Z-2257-2010 | REF 70-0073-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, RETRO, STRAIGHT, STERILE, Rx ONLY... | Linvatec Corporation | HRX | ||
| Z-2256-2010 | REF 70-0072-003, 3mm ARTHRO-KNIFE SHEATHED KNIFE, HOOK, STRAIGHT, STERILE, Rx ONLY... | Linvatec Corporation | HRX | ||
| Z-2255-2010 | REF 70-0071-113, 3mm ARTHRO-KNIFE SHEATHED KNIFE, BANANA, SERRATED LEFT, STERILE, Rx... | Linvatec Corporation | HRX | ||
| Z-2254-2010 | REF 70-0071-103, 3mm, ARTHRO-KNIFE SHEATHED KNIFE, BANANA, SERRATED STRAIGHT, STERILE, Rx... | Linvatec Corporation | HRX | ||
| Z-2253-2010 | REF C4000 INTEQ TFCC SMALL JOINT SUTURING SYSTEM KITS, STERILE, Rx ONLY. CONMED... | Linvatec Corporation | HRX | ||
| Z-2252-2010 | C-REAMER CANNULATED, STERILE, Rx ONLY. REF 8772A, 9.0MM, QTY DIST 712. REF 8773A... | Linvatec Corporation | LXH | ||
| Z-2251-2010 | REF, 9973, 2.4mm ARTHROSCOPY KNIFE, BANANA STYLE, SMALL JOINT, STERILE, Rx ONLY... | Linvatec Corporation | HRX | ||
| Z-2250-2010 | REF 9906, DIGIT TRAP FINGER GRASPING DEVICE, STERILE. CONMED LINVATEC, 11311 CONCEPT... | Linvatec Corporation | KDC | ||
| Z-2249-2010 | REF 9903, DIGIT TRAP FINGER GRASPING DEVICE, LARGE STERILE. CONMED LINVATEC, 11311... | Linvatec Corporation | KDC | ||
| Z-2248-2010 | REF 8788, 8mm C-REAMER, CANNULATED, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT... | Linvatec Corporation | LXH | ||
| Z-2247-2010 | REF 8787, 7mm C-REAMER, CANNULATED, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT... | Linvatec Corporation | LXH | ||
| Z-2246-2010 | REF 8586, 6mm C-REAMER, CANNULATED, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT... | Linvatec Corporation | LXH | ||
| Z-2245-2010 | REF 8570 MENISCAL REPAIR NEEDLE, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD... | Linvatec Corporation | HWQ | ||
| Z-1421-2010 | Cordis, AVANTI+ Introducer, STERILE EO, For one use only. Catalog 402656X Lot #... | Cordis US Corp. | DYB | ||
| Z-0806-2010 | Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-210, 10 x... | Merit Medical Systems, Inc. | FGE | ||
| Z-0805-2010 | Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-209, 10 x... | Merit Medical Systems, Inc. | FGE | ||
| Z-0804-2010 | Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-208, 10 x... | Merit Medical Systems, Inc. | FGE | ||
| Z-0803-2010 | Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-206, 8 x 80... | Merit Medical Systems, Inc. | FGE | ||
| Z-0802-2010 | Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-205, 8 x 60... | Merit Medical Systems, Inc. | FGE | ||
| Z-0801-2010 | Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-204, 8 x 40... | Merit Medical Systems, Inc. | FGE | ||
| Z-1899-2010 | Horizon Cardiology Hemo Monitoring System A programmable diagnostic computer intended... | Change Healthcare Technologies LLC | DQK | ||
| Z-1082-2010 | Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only... | Abbott Medical | MEA | ||
| Z-0807-2010 | StatSpin Express 4 Horizontal Centrifuge Model # M510. Intended Use: Rapid... | StatSpin, Inc., dba Iris Sample Processing | JQC | ||
| Z-0915-2010 | NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left... | Zimmer GmbH | JWH | ||
| Z-0120-2011 | NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 3, REF... | Zimmer GmbH | JWH | ||
| Z-0119-2011 | NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 6, REF... | Zimmer GmbH | JWH | ||
| Z-1562-2011 | Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2... | Bio-Rad Laboratories Inc. | JNB | ||
| Z-1108-2010 | ACM Bio-Prep with Merocel pkg/6, Rx, Sterile, REF 0306-708-000S4, Stryker Instruments... | Stryker Corp. | GDY | ||
| Z-1107-2010 | ACM with Femoral Brush and Femoral Sponge, Rx, Sterile, REF 306-705-000S8, Stryker... | Stryker Corp. | GDY | ||
| Z-1106-2010 | Advanced Cement Mixing Bio-Prep Cement Application Kit, Rx, Sterile, REF 306-563S10... | Stryker Corp. | GDY | ||
| Z-1105-2010 | Bio-Prep Bone Preparation Kit with Merocel sponge for use in total hip arthroplasty. REF... | Stryker Corp. | GDY | ||
| Z-1104-2010 | Femoral Sponge 10 inches REF 206-715, Rx Sterile, Stryker Instruments Kalamazoo... | Stryker Corp. | GDY | ||
| Z-1149-2010 | BD Shigella poly Group D Antiserum S. sonnei; types I,II, packaged in 3 mL vials, Catalog... | Becton Dickinson & Co | LIA | ||
| Z-2502-2010 | GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical... | American Medical Systems Innovation Center - Silicon Valley | GEX | ||
| Z-0449-2011 | Siemens brand ARTISTE MV, Artiste Digital Linear Accelerators in combination with the... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1142-2010 | Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref Code 3405M. | ConvaTec Limited | GEI | ||
| Z-1148-2010 | Paraffin Pretreatment Reagent Kit III; each kit contains the following: 5 x 50 mL... | Abbott Molecular, Inc. | KEO | ||
| Z-1147-2010 | Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50 mL... | Abbott Molecular, Inc. | KEO | ||
| Z-1759-2010 | COULTER PrepPlus 2, Part Number: 378600 | Siemens Healthcare Diagnostics Inc. | JQW | ||
| Z-1758-2010 | COULTER PrepPlus, Part Number: 286600 | Siemens Healthcare Diagnostics Inc. | JQW | ||
| Z-0849-2010 | EasyDiagnost. Multi-functional R/F systems used for general R/F, Fluoroscopy... | Philips North America LLC | IXR | ||
| Z-0848-2010 | BuckyDiagnost. General Radiography and Tomography examination of patients in supine... | Philips North America LLC | KPR | ||
| Z-0847-2010 | DigitalDiagnost. General radiographic examinations and applications wherever a solid... | Philips North America LLC | MQB | ||
| Z-1201-2010 | Howmedica Restoration ADM Trial Cup Holder; Non Sterile; Benoist Girard, Cedex... | Howmedica Osteonics Corp | MEH | ||
| Z-1162-2010 | SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550... | Medtronic, Inc. | MCW | ||
| Z-0654-2013 | Class II | Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and... | Lockheed Martin Gyrocam Systems, Inc. | REX |