Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 66 of 125
Zimmer Biomet, Inc.
Class II Terminated
Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.
Reason: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if crack...
Z-1806-2018 May 23, 2018 Warsaw, IN
Abbott
Class I Terminated
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory lef...
Reason: Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can res...
Z-1774-2018 May 23, 2018 Pleasanton, CA
Zimmer Biomet, Inc.
Class II Terminated
Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301 For use during orthopaedic surgery for implantation of a prosthesis.
Reason: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if crack...
Z-1807-2018 May 23, 2018 Warsaw, IN
Kelyniam Global, Inc.
Class II Terminated
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
Reason: Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ...
Z-1873-2018 May 23, 2018 Collinsville, CT
Medtronic Sofamor Danek USA Inc
Class II Terminated
Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments, DRILL GUIDES: a) REF 6975205, 5mm b) REF 6975206, 6mm c) REF 6975207, 7mm Product Usage: The PRESTIGE LP reusable i...
Reason: The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill gu...
Z-1641-2018 May 16, 2018 Memphis, TN
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1767-2018 May 16, 2018 Tempe, AZ
DePuy Orthopaedics, Inc.
Class II Terminated
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
Reason: There may be burrs on the extraction hole threads.
Z-1703-2018 May 16, 2018 Warsaw, IN
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1678300
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1764-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1765-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 1676300
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1762-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE isp with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter, REF 5666362
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1766-2018 May 16, 2018 Tempe, AZ
DePuy Orthopaedics, Inc.
Class II Terminated
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
Reason: There may be burrs on the extraction hole threads.
Z-1704-2018 May 16, 2018 Warsaw, IN
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678301
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1771-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 1668362
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1761-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with open suture holes, REF 5678300
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1770-2018 May 16, 2018 Tempe, AZ
Bard Brachytherapy, Inc.
Class II Terminated
BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold-cored aluminum wire (reference Figure 1 below). ...
Reason: Bard Medical Division is recalling the BARD¿ BrachySource¿ Iodine125 Radioactive Seeds in Mick¿ Applicators and BARD¿ BrachySource¿ Iodine125 Radioactive Seeds Loose in Vial w...
Z-1702-2018 May 16, 2018 Carol Stream, IL
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1676301
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1763-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter with Open Suture Holes, REF 5676301
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1769-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00004
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1772-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1768-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1760-2018 May 16, 2018 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Completed
POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP00005
Reason: The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Z-1773-2018 May 16, 2018 Tempe, AZ
Philips Electronics North America Corporation
Class II Terminated
Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human...
Reason: After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itse...
Z-1589-2018 May 9, 2018 Andover, MA
Howmedica Osteonics Corp.
Class II Terminated
Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and...
Reason: Customers may receive the incorrect size implant from what is labeled on the box.
Z-1462-2018 May 2, 2018 Mahwah, NJ
Synthes, Inc.
Class II Terminated
Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
Reason: There is a potential for the connection screw of the stem extractor to break.
Z-1514-2018 May 2, 2018 West Chester, PA