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-1774-2011 | ASR FEMORAL IMPLANT SIZE 61, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KXA | ||
| Z-1773-2011 | ASR FEMORAL IMPLANT SIZE 59, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KXA | ||
| Z-1772-2011 | ASR FEMORAL IMPLANT SIZE 57, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KXA | ||
| Z-1771-2011 | ASR FEMORAL IMPLANT SIZE 55, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KXA | ||
| Z-1770-2011 | ASR FEMORAL IMPLANT SIZE 53, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KXA | ||
| Z-1769-2011 | ASR FEMORAL IMPLANT SIZE 51, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KXA | ||
| Z-1768-2011 | ASR FEMORAL IMPLANT SIZE 49, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KXA | ||
| Z-1767-2011 | ASR FEMORAL IMPLANT SIZE 47, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KXA | ||
| Z-1766-2011 | TOTAL ASR FEM IMP SIZE 45, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KXA | ||
| Z-1765-2011 | TOTAL ASR FEM IMP SIZE 43, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KXA | ||
| Z-1764-2011 | TOTAL ASR FEM IMP SIZE 41, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KXA | ||
| Z-1763-2011 | ASR FEMORAL IMPLANT SIZE 39, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KXA | ||
| Z-1762-2011 | TOTAL ASR ACET IMP SIZE 70, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KWA | ||
| Z-1761-2011 | TOTAL ASR ACET IMP SIZE 68, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KWA | ||
| Z-1760-2011 | TOTAL ASR ACET IMP SIZE 66, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KWA | ||
| Z-1759-2011 | TOTAL ASR ACET IMP SIZE 64, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KWA | ||
| Z-1758-2011 | ASR ACETABULAR IMPLANT 62, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KWA | ||
| Z-1757-2011 | ASR ACETABULAR IMPLANT 60, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KWA | ||
| Z-1756-2011 | ASR ACETABULAR IMPLANT 58, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KWA | ||
| Z-1755-2011 | ASR ACETABULAR IMPLANT 56, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KWA | ||
| Z-1754-2011 | ASR ACETABULAR IMPLANT 54, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KWA | ||
| Z-1753-2011 | ASR ACETABULAR IMPLANT 52, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KWA | ||
| Z-1752-2011 | ASR ACETABULAR IMPLANT 50, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KWA | ||
| Z-1751-2011 | ASR ACETABULAR IMPLANT 48, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KWA | ||
| Z-1750-2011 | ASR ACETABULAR IMPLANT 46, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KWA | ||
| Z-1749-2011 | ASR ACETABULAR IMPLANT 44, DEPUY ASR ACETABULAR CUP SYSTEM, DePuy Articular Surface... | Depuy Orthopaedics Inc. | KWA | ||
| Z-1021-2011 | Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic... | Canon Medical Informatics, Inc. | LLZ | ||
| Z-0592-2011 | Microtek Medical, Inc., Microscope Drape for Zeiss Standard Model/Catalog Number... | Microtek Medical LLC | KKX | ||
| Z-0057-2011 | Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary... | Howmedica Osteonics Corp | LXH | ||
| Z-0056-2011 | Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary... | Howmedica Osteonics Corp | LXH | ||
| Z-0055-2011 | Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary... | Howmedica Osteonics Corp | LXH | ||
| Z-0054-2011 | Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary... | Howmedica Osteonics Corp | LXH | ||
| Z-0053-2011 | Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary... | Howmedica Osteonics Corp | LXH | ||
| Z-0052-2011 | Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary... | Howmedica Osteonics Corp | LXH | ||
| Z-0051-2011 | Scorpio/ NRG 4 in1 Cutting Block The Scorpio total knee system is indicated for primary... | Howmedica Osteonics Corp | LXH | ||
| Z-0050-2011 | Scorpio/ NRG 4in1 Cutting Block The Scorpio total knee system is indicated for primary... | Howmedica Osteonics Corp | LXH | ||
| Z-0049-2011 | Scorpio/ NRG 4in1 Cutting Block The Scorpio total knee system is indicated for primary... | Howmedica Osteonics Corp | LXH | ||
| Z-0005-2011 | BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy... | Verathon Inc. | IYO | ||
| Z-0004-2011 | AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects... | Verathon Inc. | IYO | ||
| Z-0003-2011 | BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with... | Verathon Inc. | IYO | ||
| Z-0426-2011 | Signa Ovation, 0.35T MR Systems (MFO 1-4). Indicated for use as a diagnostic imaging... | GE Healthcare | LNH | ||
| Z-0425-2011 | Signa OpenSpeed, 0.7T MR Systems (HFO3-5). | GE Healthcare | LNH | ||
| Z-0132-2012 | SYNCHRON CX9 Delta ALX System Part #: 473513 Product Usage: The Beckman SYNCHRON CX4... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0131-2012 | SYNCHRON CX7 Delta Clinical System Part #: 468205 Product Usage: The Beckman SYNCHRON... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0130-2012 | SYNCHRON CX7 Clinical System Part #: 756602 Product Usage: The Beckman SYNCHRON CX4... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0129-2012 | SYNCHRON CX5 CE Clinical System Part #: 448700 Product Usage: The Beckman SYNCHRON CX4... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0128-2012 | SYNCHRON CX5 Delta Clinical System Part #: 468243 Product Usage: The Beckman SYNCHRON... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0127-2012 | SYNCHRON CX5 Clinical System Part #: 759300 Product Usage: The Beckman SYNCHRON CX4... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0126-2012 | SYNCHRON CX4 CE Clinical System Part #: 756600 Product Usage: The Beckman SYNCHRON CX4... | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0125-2012 | SYNCHRON CX4 Delta Clinical System Part #: 468233 Product Usage: The Beckman SYNCHRON... | Siemens Healthcare Diagnostics Inc. | JJE |