Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator I...
Reason: The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
Z-0372-2025November 20, 2024Minneapolis, MN
Iotamotion Inc
Class IIICompleted
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controllin...
Reason: Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
Reason: Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on ...
Reason: Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on ...
Reason: Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
Z-0278-2025November 6, 2024Memphis, TN
Integra LifeSciences Corp.
Class IIOngoing
Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
Reason: Out of specification endotoxin levels.
Z-0262-2025November 6, 2024Princeton, NJ
Medtronic Neuromodulation
Class IIOngoing
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Reason: A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "...
Z-0206-2025October 30, 2024Minneapolis, MN
Medtronic Neuromodulation
Class IIOngoing
Vanta Implantable Neurostimulator (INS), Model 977006
Reason: Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.
Z-0132-2025October 23, 2024Minneapolis, MN
XTANT Medical Holdings, Inc
Class IIOngoing
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Reason: Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and...
Z-0125-2025October 23, 2024Belgrade, MT
Spineology, Inc.
Class IIOngoing
The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deplo...
Reason: Possible detachment of the Graft Tube shaft from the Graft Tube funnel head when it is not used as instructed by our surgical technique.
Z-0117-2025October 23, 2024Saint Paul, MN
Howmedica Osteonics Corp.
Class IIOngoing
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee S...
Reason: Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibi...
Z-0023-2025October 16, 2024Mahwah, NJ
Cook Biotech, Inc.
Class IIOngoing
Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601
Reason: Products expire prior to the expiration date printed on the product labeling
Z-3258-2024October 2, 2024W Lafayette, IN
Cook Biotech, Inc.
Class IIOngoing
Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
Reason: Products expire prior to the expiration date printed on the product labeling
Z-3259-2024October 2, 2024W Lafayette, IN
Cook Biotech, Inc.
Class IIOngoing
Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54613
Reason: Products expire prior to the expiration date printed on the product labeling
Z-3253-2024October 2, 2024W Lafayette, IN
Cook Biotech, Inc.
Class IIOngoing
Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
Reason: Products expire prior to the expiration date printed on the product labeling
Z-3251-2024October 2, 2024W Lafayette, IN
Cook Biotech, Inc.
Class IIOngoing
Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372
Reason: Products expire prior to the expiration date printed on the product labeling
Z-3256-2024October 2, 2024W Lafayette, IN
TMJ Solutions Inc
Class IIOngoing
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Man...
Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46373
Reason: Products expire prior to the expiration date printed on the product labeling
Z-3257-2024October 2, 2024W Lafayette, IN
Cook Biotech, Inc.
Class IIOngoing
Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603
Reason: Products expire prior to the expiration date printed on the product labeling
Z-3260-2024October 2, 2024W Lafayette, IN
Cook Biotech, Inc.
Class IIOngoing
Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24667
Reason: Products expire prior to the expiration date printed on the product labeling
Z-3250-2024October 2, 2024W Lafayette, IN
Cook Biotech, Inc.
Class IIOngoing
Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612
Reason: Products expire prior to the expiration date printed on the product labeling
Z-3252-2024October 2, 2024W Lafayette, IN
Cook Biotech, Inc.
Class IIOngoing
Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46374
Reason: Products expire prior to the expiration date printed on the product labeling
Z-3255-2024October 2, 2024W Lafayette, IN
Cook Biotech, Inc.
Class IIOngoing
Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54614
Reason: Products expire prior to the expiration date printed on the product labeling
Z-3254-2024October 2, 2024W Lafayette, IN
Innovasis, Inc
Class IIOngoing
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone ...
Reason: Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.