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-0781-2016 | Class II | IMPLANT,TM, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMTB10 Product... | ZimVie US Corp LLC | DZE | |
| Z-0780-2016 | Class II | IMPLANT,TM, MTX FULL 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMT4B13 Product... | ZimVie US Corp LLC | DZE | |
| Z-0779-2016 | Class II | IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 Product... | ZimVie US Corp LLC | DZE | |
| Z-0778-2016 | Class II | IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 Product... | ZimVie US Corp LLC | DZE | |
| Z-0777-2016 | Class II | IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product Usage: Zimmer... | ZimVie US Corp LLC | DZE | |
| Z-0776-2016 | Class II | IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 Product Usage: Zimmer... | ZimVie US Corp LLC | DZE | |
| Z-0775-2016 | Class II | IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer Dental... | ZimVie US Corp LLC | DZE | |
| Z-0774-2016 | Class II | IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product Usage: Zimmer... | ZimVie US Corp LLC | DZE | |
| Z-0773-2016 | Class II | IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 Product Usage: Zimmer... | ZimVie US Corp LLC | DZE | |
| Z-0772-2016 | Class II | IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product Usage: Zimmer... | ZimVie US Corp LLC | DZE | |
| Z-1175-2017 | Class II | Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B Product... | Biomet U.K., Ltd. | NRA | |
| Z-1174-2017 | Class II | Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B Product... | Biomet U.K., Ltd. | NRA | |
| Z-1173-2017 | Class II | Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Product... | Biomet U.K., Ltd. | NRA | |
| Z-1172-2017 | Class II | Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C Product... | Biomet U.K., Ltd. | NRA | |
| Z-1171-2017 | Class II | Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D Product... | Biomet U.K., Ltd. | NRA | |
| Z-1170-2017 | Class II | Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with... | Biomet U.K., Ltd. | LXH | |
| Z-1169-2017 | Class II | Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with... | Biomet U.K., Ltd. | LXH | |
| Z-1168-2017 | Class II | Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for use with... | Biomet U.K., Ltd. | LXH | |
| Z-1167-2017 | Class II | Oxford Partial Knee System Left Medial Tibial Trial Tray Size B Product... | Biomet U.K., Ltd. | NRA | |
| Z-1166-2017 | Class II | Oxford Partial Knee System Right Medial Tibial Trial Tray Size B Product... | Biomet U.K., Ltd. | NRA | |
| Z-1165-2017 | Class II | Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Partial Knee... | Biomet U.K., Ltd. | NRA | |
| Z-1164-2017 | Class II | Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Product... | Biomet U.K., Ltd. | NRA | |
| Z-1163-2017 | Class II | Oxford Partial Knee System Left Medial Tibial Trial Tray Size D Product... | Biomet U.K., Ltd. | NRA | |
| Z-1162-2017 | Class II | Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product... | Biomet U.K., Ltd. | NRA | |
| Z-1161-2017 | Class II | Oxford Partial Knee System Left Medial Tibial Trial Tray Size E Product... | Biomet U.K., Ltd. | NRA | |
| Z-1160-2017 | Class II | Oxford Partial Knee System Right Medial Tibial Trial Tray Size E Product... | Biomet U.K., Ltd. | NRA | |
| Z-1159-2017 | Class II | Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product... | Biomet U.K., Ltd. | NRA | |
| Z-1158-2017 | Class II | Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product... | Biomet U.K., Ltd. | NRA | |
| Z-1157-2017 | Class II | Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product... | Biomet U.K., Ltd. | NRA | |
| Z-1156-2017 | Class II | Oxford Partial Knee System Right Medial Tibial Trial Tray Size F Product... | Biomet U.K., Ltd. | NRA | |
| Z-1155-2017 | Class II | Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product... | Biomet U.K., Ltd. | HWR | |
| Z-1154-2017 | Class II | Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use... | Biomet U.K., Ltd. | HWR | |
| Z-1153-2017 | Class II | Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with... | Biomet U.K., Ltd. | LXH | |
| Z-1152-2017 | Class II | Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments for use... | Biomet U.K., Ltd. | LXH | |
| Z-0796-2016 | Class II | T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use... | Salter Labs | CAF | |
| Z-0786-2016 | Class II | Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for... | Bard Peripheral Vascular Inc | DSY | |
| Z-0785-2016 | Class II | Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for... | Bard Peripheral Vascular Inc | DSY | |
| Z-0676-2016 | Class II | InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single... | RyMed Technologies, LLC | FPA | |
| Z-0675-2016 | Class II | InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single... | RyMed Technologies, LLC | FPA | |
| Z-0854-2016 | Class II | Philips IntelliVue Module Measurement X2 Model: M3002A | Philips North America LLC | MHX | |
| Z-0853-2016 | Class II | Philips IntelliVue Measurement Module X1 Model: M3001A | Philips North America LLC | MHX | |
| Z-0812-2016 | Class III | REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single... | C.R. Bard Inc | KYZ | |
| Z-0608-2016 | Class II | Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for... | Otto Bock Healthcare LP | ISY | |
| Z-1174-2016 | Class II | CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath... | Cordis US Corp. | DRE | |
| Z-0687-2016 | Class II | The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution... | Siemens Medical Solutions USA, Inc. | JAK | |
| Z-0823-2016 | Class II | This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended... | Leica Microsystems, Inc. | NJT | |
| Z-0795-2016 | Class II | PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative... | Pharmacaribe LLC | CAF | |
| Z-0754-2016 | Class II | ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog... | Siemens Healthcare Diagnostics Inc. | MTF | |
| Z-0748-2016 | Class II | AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay... | Radiometer America, Inc | CHL | |
| Z-0697-2016 | Class II | EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the... | Phadia AB | LKP |