Reason: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Z-2424-2025September 3, 2025Parsippany, NJ
Bausch & Lomb Surgical, Inc.
Class IIIOngoing
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Reason: An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visua...
Reason: The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage appr...
Reason: The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage appr...
Z-2421-2025September 3, 2025Waltham, MA
Boston Scientific Neuromodulation Corporation
Class IIOngoing
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
Reason: Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) ...
Reason: Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacem...
Z-2325-2025August 27, 2025Saint Paul, MN
Thoratec LLC
Class IOngoing
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) ...
Reason: Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintend...
Z-2290-2025August 20, 2025Pleasanton, CA
Thoratec LLC
Class IOngoing
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equ...
Reason: Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintend...
Z-2291-2025August 20, 2025Pleasanton, CA
Encore Medical, LP
Class IIOngoing
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment o...
Reason: Knee implants contain incorrect labeling (size and/or side incorrect)
Z-2285-2025August 20, 2025Austin, TX
Encore Medical, LP
Class IIOngoing
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment o...
Reason: Knee implants contain incorrect labeling (size and/or side incorrect)
Z-2286-2025August 20, 2025Austin, TX
Implant Direct Sybron Manufacturing LLC
Class IIOngoing
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit i...
Reason: The Drill stop kit contains incorrect components.
Reason: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Z-2148-2025July 30, 2025Austin, TX
Encore Medical, LP
Class IIOngoing
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices a...
Reason: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could resu...
Z-2125-2025July 23, 2025Austin, TX
Encore Medical, LP
Class IIOngoing
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices a...
Reason: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could resu...
Z-2126-2025July 23, 2025Austin, TX
Canary Medical, Inc.
Class IIOngoing
Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee Syst...
Reason: Due to labeling error. Product incorrectly labeled.
Reason: Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Z-1988-2025June 25, 2025Irvine, CA
Orthofix Srl
Class IIOngoing
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Reason: Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion resulting in having to be replaced.
Z-1977-2025June 25, 2025Bussolengo, N/A
Preat Corp
Class IIOngoing
Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arc...
Reason: Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the ass...
Reason: Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Z-1989-2025June 25, 2025Irvine, CA
Prismatik Dentalcraft, Inc.
Class IIOngoing
Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for...
Reason: Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Z-1856-2025June 4, 2025Irvine, CA
Onkos Surgical, Inc.
Class IIOngoing
ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.
Reason: Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package....