Reason: Their is a potential that intraocular implant devices may not meet specifications.
Z-0471-2024December 13, 2023Monrovia, CA
Heartware, Inc.
Class IIOngoing
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault]...
Z-0477-2024December 13, 2023Miami Lakes, FL
Heartware, Inc.
Class IIOngoing
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault]...
Z-0479-2024December 13, 2023Miami Lakes, FL
Staar Surgical Company
Class IIOngoing
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Reason: Their is a potential that intraocular implant devices may not meet specifications.
Z-0469-2024December 13, 2023Monrovia, CA
Staar Surgical Company
Class IIOngoing
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Reason: Their is a potential that intraocular implant devices may not meet specifications.
Z-0467-2024December 13, 2023Monrovia, CA
Staar Surgical Company
Class IIOngoing
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens.
Reason: Their is a potential that intraocular implant devices may not meet specifications.
Reason: Their is a potential that intraocular implant devices may not meet specifications.
Z-0470-2024December 13, 2023Monrovia, CA
Heartware, Inc.
Class IIOngoing
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault]...
Reason: Their is a potential that intraocular implant devices may not meet specifications.
Z-0464-2024December 13, 2023Monrovia, CA
Heartware, Inc.
Class IIOngoing
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault]...
Reason: Their is a potential that intraocular implant devices may not meet specifications.
Z-0473-2024December 13, 2023Monrovia, CA
Heartware, Inc.
Class IIOngoing
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault]...
Z-0482-2024December 13, 2023Miami Lakes, FL
Staar Surgical Company
Class IIOngoing
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
Reason: Their is a potential that intraocular implant devices may not meet specifications.
Z-0474-2024December 13, 2023Monrovia, CA
Heartware, Inc.
Class IIOngoing
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Reason: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault]...
Reason: Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in su...
Reason: Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024.
Z-0235-2024November 15, 2023Redwood City, CA
Encore Medical, LP
Class IIOngoing
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Reason: Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in su...
Z-0281-2024November 15, 2023Austin, TX
Medtronic Neuromodulation
Class IICompleted
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Reason: There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD p...
Z-0217-2024November 8, 2023Minneapolis, MN
Preat Corp
Class IIOngoing
Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Reason: The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
Z-0152-2024November 1, 2023Santa Maria, CA
Preat Corp
Class IIOngoing
Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
Reason: The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
Z-0154-2024November 1, 2023Santa Maria, CA
Preat Corp
Class IIOngoing
Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Reason: The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
Z-0153-2024November 1, 2023Santa Maria, CA
Cardinal Health 200, LLC
Class IIOngoing
Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular....
Reason: Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an ext...