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-2552-2014 | Class II | Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT... | Zimmer GmbH | JWH | |
| Z-2551-2014 | Class II | Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP... | Zimmer GmbH | JDG | |
| Z-2550-2014 | Class II | Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT... | Zimmer GmbH | HRS | |
| Z-2549-2014 | Class II | Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE... | Zimmer GmbH | HWC | |
| Z-2548-2014 | Class II | Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA... | Zimmer GmbH | JDI | |
| Z-2547-2014 | Class II | Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO... | Zimmer GmbH | JDI | |
| Z-2251-2014 | Class II | 4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer | Zimmer GmbH | HWC | |
| Z-2250-2014 | Class II | 4.5 mm Malleolar Screw Sterile zimmer | Zimmer GmbH | HWC | |
| Z-2249-2014 | Class II | 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer | Zimmer GmbH | HWC | |
| Z-2248-2014 | Class II | 6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer | Zimmer GmbH | HWC | |
| Z-2247-2014 | Class II | 6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer | Zimmer GmbH | HWC | |
| Z-2246-2014 | Class II | 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer | Zimmer GmbH | HWC | |
| Z-2245-2014 | Class II | Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zimmer | Zimmer GmbH | HWC | |
| Z-2244-2014 | Class II | Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile zimmer | Zimmer GmbH | HWC | |
| Z-2546-2014 | Class II | Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW... | Zimmer GmbH | LXH | |
| Z-2656-2014 | Class II | Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741... | GF Health Products, Inc. | FNL | |
| Z-2179-2014 | Class II | Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The... | Medtronic, Inc. | MDS | |
| Z-0041-2015 | Class II | RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product... | Smith & Nephew, Inc. | OMP | |
| Z-0040-2015 | Class II | RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ... | Smith & Nephew, Inc. | OMP | |
| Z-0039-2015 | Class II | RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ... | Smith & Nephew, Inc. | OMP | |
| Z-2650-2014 | Class III | Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended... | Diagnostica Stago, Inc. | KFF | |
| Z-2207-2014 | Class II | X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541 | Gambro Renal Products | FLD | |
| Z-2206-2014 | Class II | PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment... | Gambro Renal Products | FLD | |
| Z-2165-2014 | Class II | Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing... | Abbott Medical | DRS | |
| Z-2164-2014 | Class II | Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe... | Abbott Medical | DRS | |
| Z-2163-2014 | Class II | Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No... | Abbott Medical | DRS | |
| Z-2162-2014 | Class II | Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP... | Abbott Medical | DRS | |
| Z-2161-2014 | Class II | Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item... | Abbott Medical | DRS | |
| Z-2160-2014 | Class II | Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6... | Abbott Medical | DRS | |
| Z-2159-2014 | Class II | Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap... | Abbott Medical | DRS | |
| Z-2158-2014 | Class II | Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and... | Abbott Medical | DRS | |
| Z-2157-2014 | Class II | Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2... | Abbott Medical | DRS | |
| Z-2233-2014 | Class III | BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process... | Becton, Dickinson and Company, BD Biosciences | GKZ | |
| Z-2205-2014 | Class II | Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4... | Gambro Renal Products | KDI | |
| Z-2204-2014 | Class II | Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4... | Gambro Renal Products | KDI | |
| Z-2203-2014 | Class II | Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4... | Gambro Renal Products | KDI | |
| Z-2202-2014 | Class II | Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4... | Gambro Renal Products | KDI | |
| Z-2201-2014 | Class II | Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4... | Gambro Renal Products | KDI | |
| Z-2200-2014 | Class II | Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a... | Gambro Renal Products | KDI | |
| Z-2199-2014 | Class II | Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a... | Gambro Renal Products | KDI | |
| Z-2198-2014 | Class II | Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4... | Gambro Renal Products | KDI | |
| Z-2197-2014 | Class II | Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4... | Gambro Renal Products | KDI | |
| Z-2196-2014 | Class II | Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic... | Gambro Renal Products | KDI | |
| Z-2195-2014 | Class II | Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a... | Gambro Renal Products | KDI | |
| Z-2194-2014 | Class II | Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4... | Gambro Renal Products | MDP | |
| Z-2193-2014 | Class II | Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch... | Gambro Renal Products | MDP | |
| Z-2239-2014 | Class II | TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software... | Accuray Incorporated | IYE | |
| Z-2243-2014 | Class I | CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film... | Cook Incorporated | MMX | |
| Z-2669-2014 | Class II | Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended... | Genesisbps LLC | BRZ | |
| Z-2668-2014 | Class II | Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS... | Genesisbps LLC | BRZ |
