Reason: Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titan...
Z-1111-2025February 12, 2025Tampa, FL
Nobel Biocare
Class IIOngoing
. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an en...
Reason: Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the fin...
Z-1101-2025February 12, 2025Goteborg
LivaNova USA, Inc.
Class IIOngoing
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Sti...
Reason: Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
Z-1067-2025February 5, 2025Houston, TX
Alphatec Spine, Inc.
Class IIOngoing
Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 d...
Reason: Complaints have been received regarding post-operative implant collapse.
Z-1065-2025February 5, 2025Carlsbad, CA
LivaNova USA, Inc.
Class IIOngoing
Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Va...
Reason: Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
Z-1068-2025February 5, 2025Houston, TX
Integra LifeSciences Corp.
Class IIOngoing
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hyd...
Reason: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Z-0977-2025January 29, 2025Princeton, NJ
Integrity Implants Inc.
Class IIOngoing
Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft ma...
Reason: Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
Z-1008-2025January 29, 2025Palm Beach Gardens, FL
Integra LifeSciences Corp.
Class IIOngoing
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of ...
Reason: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Z-0978-2025January 29, 2025Princeton, NJ
Integra LifeSciences Corp.
Class IIOngoing
CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hyd...
Reason: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Z-0979-2025January 29, 2025Princeton, NJ
SIN SISTEMA DE IMPLANTE NACIONAL S.A
Class IIOngoing
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Reason: Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the ...
Z-0920-2025January 22, 2025Sao Paulo
Medtronic Neuromodulation
Class IIOngoing
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
Reason: Software issues were identified in application version 2.x.
Z-0771-2025January 8, 2025Minneapolis, MN
Medtronic Neuromodulation
Class IIOngoing
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
Reason: Software issues were identified in application version 2.x.
Z-0772-2025January 8, 2025Minneapolis, MN
Medtronic Neuromodulation
Class IIOngoing
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
Reason: Software issues were identified in application version 2.x.
Z-0773-2025January 8, 2025Minneapolis, MN
Medtronic Neuromodulation
Class IIOngoing
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, C...
Reason: Software issues were identified in application version 2.x.
Z-0774-2025January 8, 2025Minneapolis, MN
Moximed, Inc.
Class IIOngoing
MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.
Reason: Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduce...
Z-0762-2025January 1, 2025Fremont, CA
Abbott Medical
Class IIOngoing
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed ...
Reason: Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small...
Z-0753-2025January 1, 2025Sylmar, CA
Limacorporate S.p.A
Class IIOngoing
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
Reason: Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Reason: Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
Z-0699-2025December 25, 2024Arlington, TN
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984...
Reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Reason: Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurrence rate of the following hazards: revision, removal, implant subsidence, displace...
Reason: Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Z-0533-2025December 4, 2024Northfield, IL
INCIPIO DEVICES
Class IIOngoing
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Reason: Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Z-0549-2025December 4, 2024St-Blaise
Abbott Medical
Class IIIOngoing
Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to fa...
Reason: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software downlo...
Z-0551-2025December 4, 2024Sylmar, CA
Abbott Medical
Class IIIOngoing
Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive inf...
Reason: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software downlo...
Z-0552-2025December 4, 2024Sylmar, CA
Novosource, LLC
Class IIOngoing
NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including ...
Reason: Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted