ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. 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....
Z-1817-2025June 4, 2025Parsippany, NJ
Straumann USA LLC
Class IIOngoing
GM Helix Acqua Implant, Article Number: 140.985
Reason: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Z-1863-2025June 4, 2025Andover, MA
Straumann USA LLC
Class IIOngoing
GM Helix Acqua Implant, Article Number: 140.984
Reason: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Reason: Vials of implant bone granules may contain less product then specified on labeling.
Z-1718-2025May 14, 2025Lourdes, N/A
Bausch & Lomb Surgical, Inc.
Class IOngoing
Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Tori...
Reason: In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVist...
Z-1679-2025May 14, 2025Clearwater, FL
Bausch & Lomb Surgical, Inc.
Class IOngoing
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Reason: In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVist...
Z-1680-2025May 14, 2025Clearwater, FL
Merit Medical Systems, Inc.
Class IIOngoing
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
Reason: Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantati...
Reason: Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
Z-1557-2025April 23, 2025Sylmar, CA
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: ...
Reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Z-1592-2025April 23, 2025Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Number: DYNJ53032C; 3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50...
Reason: There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Reason: The devices are missing the laser marked depth markings.
Z-1561-2025April 23, 2025Andover, MA
Medtronic Neuromodulation
Class IIOngoing
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
Reason: There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
Z-1543-2025April 16, 2025Minneapolis, MN
Stryker Spine
Class IIOngoing
Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
Reason: Potential for the gold unlock button to separate from the inserter.
Z-1488-2025April 9, 2025Allendale, NJ
Stryker Spine
Class IIOngoing
Monterey AL Implant Inserter; 22mm; Catalog 48019140.
Reason: Potential for the gold unlock button to separate from the inserter.
Z-1491-2025April 9, 2025Allendale, NJ
Stryker Spine
Class IIOngoing
Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
Reason: Potential for the gold unlock button to separate from the inserter.
Z-1489-2025April 9, 2025Allendale, NJ
Stryker Spine
Class IIOngoing
Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.
Reason: Potential for the gold unlock button to separate from the inserter.
Z-1490-2025April 9, 2025Allendale, NJ
Medtronic Neuromodulation
Class IIOngoing
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Reason: Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
Z-1506-2025April 9, 2025Minneapolis, MN
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pac...
Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may...
Z-1438-2025April 2, 2025Northfield, IL
Orthofix U.S. LLC
Class IIOngoing
Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm...
Reason: The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
Z-1432-2025April 2, 2025Lewisville, TX
Smiths Medical ASD, Inc.
Class IOngoing
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Z-1277-2025March 26, 2025Minneapolis, MN
Smiths Medical ASD, Inc.
Class IOngoing
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Z-1278-2025March 26, 2025Minneapolis, MN
Smiths Medical ASD, Inc.
Class IOngoing
smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.