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-1169-2012 | Depuy Mitek LUPINE BR DS W/ORTHCRD Catalog Number: 210712 The Lupine Anchor System is... | DePuy Mitek, Inc. | MAI | ||
| Z-1168-2012 | Depuy Mitek LUPINE BR W/ORTHCORD Catalog Number: 210711 The Lupine Anchor System is... | DePuy Mitek, Inc. | MAI | ||
| Z-1167-2012 | Depuy Mitek Lupine Loop Plus Anchor w/Ethibond Catalog Number: 210710 The Lupine Anchor... | DePuy Mitek, Inc. | MAI | ||
| Z-1166-2012 | Depuy Mitek LupineLoopPlus Anchor w/Orthocord DS Catalog Number: 210709 The Lupine... | DePuy Mitek, Inc. | MAI | ||
| Z-1165-2012 | Depuy Mitek Lupine Loop Plus Anchor w/Orthocord Catalog Number: 210708 The Lupine... | DePuy Mitek, Inc. | MAI | ||
| Z-1164-2012 | Depuy Mitek- Lupine Loop Plus Anchor w/ Panacryl Catalog Number: 210707 The Lupine... | DePuy Mitek, Inc. | MAI | ||
| Z-1163-2012 | Depuy Mitek- Lupine (Panalok) Loop Arthro #2 Panacryl Catalog Number: 210705 The Lupine... | DePuy Mitek, Inc. | MAI | ||
| Z-1162-2012 | Depuy Mitek Lupine (Panalok) Loop Arthro #2 Ethibond Catalog Number: 210704 The Lupine... | DePuy Mitek, Inc. | MAI | ||
| Z-1104-2012 | Presource Custom Sterile Surgical and Procedure Kits containing Ethicon Ethilon Black... | Medtronic, Inc. | LRO | ||
| Z-1125-2012 | Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of... | Philips Medical Systems Nederland B.V. | LNH | ||
| Z-2016-2012 | Class II | Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH... | Howmedica Osteonics Corp | HSB | |
| Z-1369-2012 | GEMINI TF 16, 64 & Big Bore Computed Tomography X-Ray Systems, M/N 882470, 882471 &... | Philips North America LLC | KPS | ||
| Z-1368-2012 | GEMINI GXL 6, 10 & 16 Computed Tomography X-Ray Systems, M/N 882390, 882400 & 882410... | Philips North America LLC | KPS | ||
| Z-1367-2012 | Extended Brilliance Workstation Computed Tomography X-Ray Systems, M/N 728260... | Philips North America LLC | JAK | ||
| Z-1366-2012 | Brilliance Big Bore Computed Tomography X-Ray Systems, M/N 728243, 728244, Distributed... | Philips North America LLC | JAK | ||
| Z-1247-2012 | ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw, Model #... | Ethicon Endo-Surgery Inc | LFL | ||
| Z-1246-2012 | ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw, Model # NSLG2S14 and... | Ethicon Endo-Surgery Inc | LFL | ||
| Z-1245-2012 | ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Curved Jaw, Model #... | Ethicon Endo-Surgery Inc | LFL | ||
| Z-1244-2012 | ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw, Model # NSLG2C14 and... | Ethicon Endo-Surgery Inc | GEI | ||
| Z-1064-2012 | Siemens syngo Imaging XS. Radiological image processing system. | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-1066-2012 | Elekta Synergy XVI 4.5 and R4.6 To be used as part of radiation therapy treatment... | Elekta Limited | IYE | ||
| Z-1080-2012 | CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG... | Halyard Health | KNT | ||
| Z-0940-2012 | Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915. Nuclear magnetic... | Siemens Medical Solutions USA, Inc. | LNH | ||
| Z-1385-2012 | VariSeed 7.1, software application, part number H62, manufactured by Varian Medical... | Varian Medical Systems, Inc. | KXK | ||
| Z-1237-2012 | REF 905948, 2.MM Hitch Suture (Lactosorb Anchor L15 2#1,(Lactosorb L-15 resorbable... | Zimmer GmbH | HWC | ||
| Z-1236-2012 | REF 905581, 6.8 mm Lactoscrew 2#2 MB wI NDL, (Lactosorb L-15 resorbable copolymer )... | Zimmer GmbH | HWC | ||
| Z-1235-2012 | REF 905580, 6. 8 mm Lactoscrew 2#2 MBNo. (Lactosorb L-15 resorbable copolymer ) Sterile... | Zimmer GmbH | HWC | ||
| Z-1234-2012 | REF 905572, 5.5mm Lactoscrew Anchor,WI Maxbraid No Nd (Lactosorb L-15 resorbable... | Zimmer GmbH | HWC | ||
| Z-1233-2012 | REF 905571, 5.5 mm Lactoscrew Anchors,WITH Needles #2 Maxbraid (Lactosorb L-15 resorbable... | Zimmer GmbH | HWC | ||
| Z-1232-2012 | REF 905570 3.5 mm Lactoscrew Anchor Size 2 white Maxbraid ,(Lactosorb L-15 resorbable... | Zimmer GmbH | HWC | ||
| Z-1231-2012 | REF 905463, 2.9 mm Micromax Anchor Long Shaft, Size 2 Blue/White Maxbraid (Lactosorb L-15... | Zimmer GmbH | HWC | ||
| Z-1274-2012 | IMMULITE 2500 CK-MB L5KCP --- Catalog number: L5KCP2 (200 tests), L5KCP6 (600 tests)... | Siemens Healthcare Diagnostics Inc. | JHX | ||
| Z-1273-2012 | IMMULITE 2000/IMMULITE 2000 XPi CK-MB L2KMB --- Catalog number: L2KMB2 (200 tests)... | Siemens Healthcare Diagnostics Inc. | JHX | ||
| Z-1272-2012 | IMMULITE/IMMULITE Turbo 1000 CK-MB LSKCP --- Catalog number: LSKCP1 (100 tests), LSKCP5... | Siemens Healthcare Diagnostics Inc. | JHX | ||
| Z-1271-2012 | IMMULITE/IMMULITE 1000 CK-MB LKMB --- Catalog number: LKMB1 (100 tests), LKMB5 (500... | Siemens Healthcare Diagnostics Inc. | JHX | ||
| Z-2366-2012 | Class II | REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm... | Exactech, Inc. | HTW | |
| Z-2365-2012 | Class II | REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm... | Exactech, Inc. | HTW | |
| Z-2364-2012 | Class II | REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm... | Exactech, Inc. | HTW | |
| Z-2363-2012 | Class II | REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm... | Exactech, Inc. | HTW | |
| Z-2362-2012 | Class II | REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm... | Exactech, Inc. | HTW | |
| Z-2361-2012 | Class II | REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm... | Exactech, Inc. | HTW | |
| Z-1455-2012 | Quintex Cervical Plating System - Screws. The Quintex Cervical Plating System is intended... | Aesculap Inc | KWQ | ||
| Z-1083-2013 | Class II | VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200... | GE Healthcare | IZL | |
| Z-1187-2012 | Integra InterFix CT Adapter (CTA) Intended for cranial fixation during CT scanning... | Integra LifeSciences Corporation | IYE | ||
| Z-1176-2012 | Cell Marque CD7 (MRQ-12); Mouse Monoclonal Antibody, Antibody is bottle in HDPE bottle... | Cell Marque Corp. | NJT | ||
| Z-0741-2012 | STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer... | Advanced Sterilization Products | MLR | ||
| Z-1092-2012 | ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0016-2013 | Class II | Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100... | Siemens Healthcare Diagnostics Inc. | CIB | |
| Z-0002-2013 | Class II | COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a... | Siemens Healthcare Diagnostics Inc. | JQW | |
| Z-1398-2012 | DeRoyal (R) Umbilicup, REF 72-8000NS, Rx Only, Manufactured by DeRoyal, Powell, TN... | DeRoyal Industries, Inc. | KSR |