Reason: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Z-2191-2024July 3, 2024Mounds View, MN
Medtronic Inc.
Class IIOngoing
MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
Reason: Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Z-2201-2024July 3, 2024Mounds View, MN
Exactech, Inc.
Class IIOngoing
OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: a) 200-07-26, 26MM; b) 200-07-29, 29MM; c) 200-07-32, 32MM; d) 200-07-35, 35MM; e) 200-07-38, 38MM
Reason: Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Z-2158-2024June 26, 2024Gainesville, FL
Synthes (USA) Products LLC
Class IIOngoing
STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010
Reason: Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay
Z-1916-2024June 5, 2024West Chester, PA
Boston Scientific Neuromodulation Corporation
Class IIOngoing
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
Reason: Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead tr...
Z-1890-2024June 5, 2024Valencia, CA
Tornier S.A.S.
Class IIOngoing
Stryker Blueprint Software, Catalog #BPUE001.
Reason: The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible ...
Z-1883-2024May 29, 2024Montbonnot St Martin
Wishbone Medical, Inc.
Class IIOngoing
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Reason: The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated.
Z-1808-2024May 22, 2024Warsaw, IN
Sophysa S.A.
Class IIOngoing
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for us...
Reason: An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could p...
Z-1826-2024May 22, 2024Orsay, N/A
Sophysa S.A.
Class IIOngoing
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventric...
Reason: An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could p...
Reason: Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
Z-1693-2024May 8, 2024Pleasanton, CA
Allergan Sales, LLC
Class IIOngoing
Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,
Reason: Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure.
Reason: Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Z-1605-2024May 1, 2024Carlsbad, CA
SEASPINE ORTHOPEDICS CORPORATION
Class IIOngoing
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
Reason: Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Z-1620-2024May 1, 2024Carlsbad, CA
RAYSEARCH LABORATORIES AB
Class IIOngoing
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
Reason: A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
Z-1482-2024April 17, 2024Stockholm, N/A
Thoratec Corp.
Class IOngoing
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, ...
Reason: Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Z-1301-2024March 27, 2024Pleasanton, CA
Thoratec Corp.
Class IOngoing
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit...
Reason: Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Z-1300-2024March 27, 2024Pleasanton, CA
Preat Corp
Class IIOngoing
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
Reason: Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant.
Reason: The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
Z-1322-2024March 27, 2024Bettlach
Synthes (USA) Products LLC
Class IIOngoing
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullar...
Reason: Products not sterilized, sterility cannot be confirmed
Z-1237-2024March 13, 2024West Chester, PA
United Orthopedic Corporation
Class IIOngoing
USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm,...
Reason: Their is a potential that the implant curved stem may be oriented incorrectly.
Z-1215-2024March 6, 2024Hsinchu
Alphatec Spine, Inc.
Class IIOngoing
IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350...
Reason: Due to reports of intraoperative graft bolt implantation breakages.