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-0626-2021 | Class II | RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone. | Zimmer GmbH | HWC | |
| Z-0625-2021 | Class II | PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044... | Zimmer GmbH | HSB | |
| Z-0624-2021 | Class II | Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage... | Zimmer GmbH | HRY | |
| Z-0623-2021 | Class II | OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in... | Zimmer GmbH | JDI | |
| Z-0622-2021 | Class II | M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage... | Zimmer GmbH | LPH | |
| Z-0621-2021 | Class II | Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1... | Zimmer GmbH | LPH | |
| Z-0620-2021 | Class II | Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number... | Zimmer GmbH | KWS | |
| Z-0619-2021 | Class II | Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398... | Zimmer GmbH | KWS | |
| Z-0618-2021 | Class II | 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm)... | Zimmer GmbH | HWC | |
| Z-0617-2021 | Class II | 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm)... | Zimmer GmbH | HWC | |
| Z-0616-2021 | Class II | 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm)... | Zimmer GmbH | HWC | |
| Z-0771-2021 | Class II | SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0611-2021 | Class I | Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN... | Cook Incorporated | DYB | |
| Z-0610-2021 | Class I | Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN... | Cook Incorporated | DYB | |
| Z-0609-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228... | Cook Incorporated | DYB | |
| Z-0608-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223... | Cook Incorporated | DYB | |
| Z-0607-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045... | Cook Incorporated | DYB | |
| Z-0606-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233... | Cook Incorporated | DYB | |
| Z-0605-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227... | Cook Incorporated | DYB | |
| Z-0604-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222... | Cook Incorporated | DYB | |
| Z-0603-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043... | Cook Incorporated | DYB | |
| Z-0602-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232... | Cook Incorporated | DYB | |
| Z-0601-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226... | Cook Incorporated | DYB | |
| Z-0600-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221... | Cook Incorporated | DYB | |
| Z-0599-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236... | Cook Incorporated | DYB | |
| Z-0598-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231... | Cook Incorporated | DYB | |
| Z-0597-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225... | Cook Incorporated | DYB | |
| Z-0596-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220... | Cook Incorporated | DYB | |
| Z-0595-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235... | Cook Incorporated | DYB | |
| Z-0594-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230... | Cook Incorporated | DYB | |
| Z-0593-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-4.0-35-70-RB-HFANL0-HC, Order Number G56219... | Cook Incorporated | DYB | |
| Z-0592-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL1-HC, Order Number G56234... | Cook Incorporated | DYB | |
| Z-0591-2021 | Class I | Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229... | Cook Incorporated | DYB | |
| Z-1342-2021 | Class II | LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay... | Diasorin Inc. | CEW | |
| Z-0877-2021 | Class II | uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and... | Roche Molecular Systems Inc | NQN | |
| Z-0695-2021 | Class II | Revolution CT with Apex Edition CT System - Product Usage: intended for head, whole body... | GE Healthcare | JAK | |
| Z-0841-2021 | Class II | Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0840-2021 | Class II | Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0839-2021 | Class II | Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0838-2021 | Class II | Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0837-2021 | Class II | Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0836-2021 | Class II | Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0835-2021 | Class II | Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0834-2021 | Class II | Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0833-2021 | Class II | Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0832-2021 | Class II | Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0831-2021 | Class II | Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0694-2021 | Class II | Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular... | GE Healthcare | JAK | |
| Z-0752-2021 | Class II | cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete)... | Roche Diagnostics GmbH | JJE | |
| Z-0722-2021 | Class II | Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro... | Siemens Healthcare Diagnostics Inc. | JQA |