Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Z-1286-2025March 26, 2025Minneapolis, MN
Smiths Medical ASD, Inc.
Class IOngoing
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Z-1284-2025March 26, 2025Minneapolis, MN
Stryker Corporation
Class IIOngoing
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Reason: Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.
Z-1328-2025March 19, 2025San Jose, CA
Hiossen Inc.
Class IIOngoing
ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. GA4515MP Model/Catal...
Reason: Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the E...
Z-1271-2025March 12, 2025Fairless Hills, PA
TAS Medical Inc
Class IIOngoing
TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
Reason: Tissue approximation straps (zip-ties) have broken before or during implantation so firm developed an interim zip-tie conditioning method submerging zip-ties in 104-degrees F steri...
Z-1294-2025March 12, 2025Windermere, FL
Hiossen Inc.
Class IIOngoing
ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number:...
Reason: Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the E...
Z-1273-2025March 12, 2025Fairless Hills, PA
Hiossen Inc.
Class IIOngoing
ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number:...
Reason: Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the E...
Z-1272-2025March 12, 2025Fairless Hills, PA
Hiossen Inc.
Class IIOngoing
ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ...
Reason: Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the E...
Z-1275-2025March 12, 2025Fairless Hills, PA
Hiossen Inc.
Class IIOngoing
Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or over...
Reason: Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the E...
Z-1276-2025March 12, 2025Fairless Hills, PA
Hiossen Inc.
Class IIOngoing
Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or over...
Reason: Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the E...
Z-1274-2025March 12, 2025Fairless Hills, PA
GE Healthcare (China) Co., Ltd.
Class IIOngoing
Brivo MR355, NMRI system
Reason: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface m...
Z-1240-2025March 5, 2025Beijing, N/A
GE Healthcare (China) Co., Ltd.
Class IIOngoing
Optima MR360, NMRI system
Reason: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface m...
Z-1241-2025March 5, 2025Beijing, N/A
GE Healthcare (China) Co., Ltd.
Class IIOngoing
SIGNA Creator, SIGNA Explorer, NMRI systems
Reason: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface m...
Z-1239-2025March 5, 2025Beijing, N/A
GE Healthcare (China) Co., Ltd.
Class IIOngoing
SIGNA MR355, SIGNA MR360, NMRI system
Reason: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface m...
Z-1242-2025March 5, 2025Beijing, N/A
GE Healthcare (China) Co., Ltd.
Class IIOngoing
SIGNA MR380, NMRI system, Non-US Only
Reason: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface m...
Z-1243-2025March 5, 2025Beijing, N/A
XTANT Medical Holdings, Inc
Class IIOngoing
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08PC (Spacer ASSY, 38 X 28 X 8¿, 19mm, PC, (STERILE...
Reason: Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.
Z-1177-2025February 26, 2025Belgrade, MT
Spectranetics Corporation
Class IOngoing
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; T...
Reason: Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in proble...
Z-1070-2025February 26, 2025Colorado Springs, CO
Angel Medical Systems, Inc.
Class IIOngoing
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event ...
Reason: Device reaching End of Service prematurely.