NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
Reason: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher over...
Z-0468-2023December 21, 2022Warsaw, IN
Zimmer, Inc.
Class IIOngoing
NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
Reason: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher over...
Z-0467-2023December 21, 2022Warsaw, IN
Zimmer, Inc.
Class IIOngoing
NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
Reason: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher over...
Z-0466-2023December 21, 2022Warsaw, IN
Zimmer, Inc.
Class IIOngoing
NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02
Reason: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher over...
Z-0471-2023December 21, 2022Warsaw, IN
Zimmer, Inc.
Class IIOngoing
NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02
Reason: Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher over...
Z-0469-2023December 21, 2022Warsaw, IN
Stradis Medical, LLC dba Stradis Healthcare
Class IIOngoing
BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray
Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in...
Z-0484-2023December 21, 2022Peachtree Corners, GA
Stradis Medical, LLC dba Stradis Healthcare
Class IIOngoing
STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in...
Z-0488-2023December 21, 2022Peachtree Corners, GA
Elekta, Inc.
Class IIOngoing
Oncentra Brachy radiation therapy planning system software.
Reason: A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
Z-0719-2023December 21, 2022Atlanta, GA
Integrity Implants Inc.
Class IITerminated
LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped ...
Reason: Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shi...
Reason: Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044
Reason: Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Z-0458-2023December 14, 2022Menlo Park, CA
Integrity Implants Inc.
Class IITerminated
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and...
Reason: Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
Reason: Due to Indirect Decompression System devices exhibiting a potential for weld breakage at the spindle cap-to-main body interface. As a result of the separation of the spindle cap f...
Z-0230-2023November 23, 2022Valencia, CA
Boston Scientific Corporation
Class IIOngoing
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Reason: There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Z-0151-2023November 9, 2022Saint Paul, MN
Boston Scientific Corporation
Class IIOngoing
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Reason: There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Z-0152-2023November 9, 2022Saint Paul, MN
MICROVENTION INC.
Class IIOngoing
WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
Reason: Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully insert...
Z-0170-2023November 9, 2022Aliso Viejo, CA
W L Gore & Associates, Inc.
Class IIOngoing
GORE CARDIOFORM ASD Occluder. cardiovascular implant.
Reason: Due to manufacturing records (Release Test Results) indicating "Failed".
Reason: Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause...
Z-0125-2023November 2, 2022Austin, TX
Angiodynamics, Inc.
Class IIOngoing
Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requ...
Reason: Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Impla...
Z-0132-2023November 2, 2022Queensbury, NY
Encore Medical, LP
Class IIOngoing
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
Reason: Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause...
Reason: The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the ster...
Z-0099-2023October 26, 2022West Chester, PA
Synthes (USA) Products LLC
Class IIOngoing
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and re...
Reason: The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the ster...
Reason: The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the ster...
Reason: The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the ster...