Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 1...
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho...
Z-2456-2019September 18, 2019Irvine, CA
Aesculap Implant Systems LLC
Class IITerminated
CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
Reason: possibility of the sterility batch being insufficiently sterilized
Z-2497-2019September 18, 2019Center Valley, PA
Allergan PLC
Class IOngoing
Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX Product Usage: Breast augmentation and Breast reconstruction
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho...
Z-2461-2019September 18, 2019Irvine, CA
Allergan PLC
Class IOngoing
Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. Product Usage: Breast augmentation and Breast reconstruction
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho...
Z-2465-2019September 18, 2019Irvine, CA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Reason: Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micr...
Z-2492-2019September 18, 2019Mounds View, MN
Allergan PLC
Class IOngoing
Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style numbers: Style 110:110-090, 110-120, 110-150, 110-180, 110-210, 110-240, 110-...
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho...
Z-2454-2019September 18, 2019Irvine, CA
Allergan PLC
Class IOngoing
Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers: Style TRL: TRL-110TRL-125,TRL-140,TRL-170,TRL-200,TRL-230,TRL-260,TRL-290,TRL-320,TRL-350,TRL-380,TRL-41...
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho...
Z-2453-2019September 18, 2019Irvine, CA
Allergan PLC
Class IOngoing
Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF Product Usage: Breast augmentation and Breast reconstruction
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho...
Z-2460-2019September 18, 2019Irvine, CA
Aesculap Implant Systems LLC
Class IITerminated
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
Reason: possibility of the sterility batch being insufficiently sterilized
Z-2496-2019September 18, 2019Center Valley, PA
Exactech, Inc.
Class IITerminated
Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically,...
Reason: The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
Z-2499-2019September 18, 2019Gainesville, FL
Allergan PLC
Class IOngoing
Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120 Soft Touch Product Usage : Breast augmentation and Breast reconstruction
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho...
Reason: An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon encountered an issue after implanting four Ad-Tech depth electrodes. Upon initial de...
Z-2396-2019September 4, 2019Oak Creek, WI
Thoratec Corp.
Class IITerminated
Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
Reason: Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft ...
Z-2349-2019August 28, 2019Pleasanton, CA
Thoratec Corp.
Class IITerminated
Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
Reason: Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft ...
Reason: Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely in...
Z-2074-2019August 14, 2019Sylmar, CA
MED-EL Elektromedizinische Gereate, Gmbh
Class IITerminated
MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible...
Reason: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Z-2138-2019August 14, 2019Innsbruck, N/A
Biomet 3i, LLC
Class IITerminated
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the max...
Reason: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positi...
Z-2140-2019August 14, 2019Palm Beach Gardens, FL
Biomet 3i, LLC
Class IITerminated
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in th...
Reason: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positi...
Z-2142-2019August 14, 2019Palm Beach Gardens, FL
Ideal Implant Incorporated
Class IITerminated
IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.
Reason: The implants were deflating due to a piece of silicone disrupting the seal of the posterior valve shortly after implantation.
Z-2219-2019August 14, 2019Dallas, TX
Biomet 3i, LLC
Class IITerminated
CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the max...
Reason: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positi...
Reason: Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely in...
Z-2073-2019August 14, 2019Sylmar, CA
Biomet 3i, LLC
Class IITerminated
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the...
Reason: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positi...
Z-2144-2019August 14, 2019Palm Beach Gardens, FL
Biomet 3i, LLC
Class IITerminated
CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in th...
Reason: During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positi...
Reason: Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely in...
Z-2072-2019August 14, 2019Sylmar, CA
MED-EL Elektromedizinische Gereate, Gmbh
Class IITerminated
MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The S...
Reason: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.