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-0332-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32mm, Neutral, O.D... | Zimmer GmbH | JDI | |
| Z-0331-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D... | Zimmer GmbH | JDI | |
| Z-0330-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D... | Zimmer GmbH | JDI | |
| Z-0329-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D... | Zimmer GmbH | JDI | |
| Z-0328-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D... | Zimmer GmbH | JDI | |
| Z-0327-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D... | Zimmer GmbH | JDI | |
| Z-0326-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D... | Zimmer GmbH | JDI | |
| Z-0325-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D... | Zimmer GmbH | JDI | |
| Z-0324-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D... | Zimmer GmbH | JDI | |
| Z-0323-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D... | Zimmer GmbH | JDI | |
| Z-0133-2021 | Class II | Yuno II Mobile Operating Table - Product Usage: support and position the patient... | Maquet Cardiovascular Us Sales, LLC | FQO | |
| Z-0132-2021 | Class II | Yuno Mobile Operating Table - Product Usage: Intended for support and position the... | Maquet Cardiovascular Us Sales, LLC | FQO | |
| Z-0453-2021 | Class II | Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage... | Medtronic, Inc. | LZH | |
| Z-0452-2021 | Class II | Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage... | Medtronic, Inc. | LZH | |
| Z-0287-2021 | Class II | Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product... | Boston Scientific Corporation | GEH | |
| Z-0319-2021 | Class II | Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I... | Boston Scientific Corporation | LWS | |
| Z-0102-2021 | Class II | Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative... | Siemens Healthcare Diagnostics Inc. | JIT | |
| Z-0101-2021 | Class II | ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the... | Siemens Healthcare Diagnostics Inc. | JIT | |
| Z-0497-2021 | Class I | ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/... | Flexicare Medical Ltd. | BTR | |
| Z-0398-2021 | Class II | TroClose 1200 - Product Usage: intended for use in a variety of gynecologic, general and... | Gordian Surgical | GAM | |
| Z-0293-2021 | Class II | 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with... | PENTAX of America, Inc. | OUG | |
| Z-0292-2021 | Class II | 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), | PENTAX of America, Inc. | OUG | |
| Z-0475-2021 | Class II | iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System... | ConforMIS, Inc. | LPH | |
| Z-0114-2021 | Class I | Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186... | Stryker Corp. | POL | |
| Z-0417-2021 | Class III | 3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a... | Synthes (USA) Products LLC | MQP | |
| Z-0416-2021 | Class III | STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral... | Synthes (USA) Products LLC | MQP | |
| Z-0415-2021 | Class III | STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral... | Synthes (USA) Products LLC | MQP | |
| Z-0414-2021 | Class III | END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product... | Synthes (USA) Products LLC | MQP | |
| Z-0413-2021 | Class III | END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product... | Synthes (USA) Products LLC | MQP | |
| Z-0412-2021 | Class III | END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product... | Synthes (USA) Products LLC | MQP | |
| Z-0411-2021 | Class III | END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product... | Synthes (USA) Products LLC | MQP | |
| Z-0410-2021 | Class III | END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral... | Synthes (USA) Products LLC | MQP | |
| Z-0409-2021 | Class III | END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral... | Synthes (USA) Products LLC | MQP | |
| Z-0408-2021 | Class III | END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral... | Synthes (USA) Products LLC | MQP | |
| Z-0407-2021 | Class III | SYNMESH 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a... | Synthes (USA) Products LLC | MQP | |
| Z-0406-2021 | Class III | SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a... | Synthes (USA) Products LLC | MQP | |
| Z-0405-2021 | Class III | SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a... | Synthes (USA) Products LLC | MQP | |
| Z-0404-2021 | Class III | SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a... | Synthes (USA) Products LLC | MQP | |
| Z-0430-2021 | Class II | Niobe ES System, Models 001-006000-1 and 001-006100-1 | Stereotaxis Inc | PJB | |
| Z-0403-2021 | Class III | DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage... | Synthes (USA) Products LLC | MQP | |
| Z-0306-2021 | Class II | Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The... | GE Healthcare | JAK | |
| Z-0298-2021 | Class II | Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0301-2021 | Class II | 5.5MM Arthrogarde Hip Access Cannula | Smith & Nephew, Inc. | NBH | |
| Z-0118-2021 | Class II | Genesis (GII) - Product Usage: designed for use in patients in primary and revision... | Smith & Nephew, Inc. | JWH | |
| Z-0400-2021 | Class II | ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intended Use: ARTIS... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0438-2021 | Class II | OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus) | Merete GmbH | HSB | |
| Z-0437-2021 | Class II | OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia) | Merete GmbH | HSB | |
| Z-0436-2021 | Class II | OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur) | Merete GmbH | HSB | |
| Z-0435-2021 | Class II | OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails | Merete GmbH | HSB | |
| Z-0317-2021 | Class II | Flow Sensor Service Part, Catalog 2096513-001-S | GE Healthcare | BSZ |