TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyop...
Reason: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Z-2856-2016September 28, 2016Santa Ana, CA
Abbott Medical Optics Inc. (AMO)
Class IITerminated
SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed ...
Reason: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Z-2855-2016September 28, 2016Santa Ana, CA
Abbott Medical Optics Inc. (AMO)
Class IITerminated
TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been r...
Reason: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
Z-2859-2016September 28, 2016Santa Ana, CA
Stryker Howmedica Osteonics Corp.
Class IITerminated
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for ...
Reason: Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument.
Z-2789-2016September 21, 2016Mahwah, NJ
Howmedica Osteonics Corp.
Class IITerminated
AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancello...
Reason: Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The c...
Z-2788-2016September 21, 2016Allendale, NJ
Howmedica Osteonics Corp.
Class IITerminated
AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellou...
Reason: Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The c...
Z-2787-2016September 21, 2016Allendale, NJ
Howmedica Osteonics Corp.
Class IITerminated
AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous...
Reason: Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The c...
Z-2786-2016September 21, 2016Allendale, NJ
Mentor Texas, LP.
Class IITerminated
CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect ...
Reason: The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Z-2781-2016September 21, 2016Irving, TX
Mentor Texas, LP.
Class IITerminated
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defec...
Reason: The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Z-2780-2016September 21, 2016Irving, TX
Mentor Texas, LP.
Class IITerminated
MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended f...
Reason: Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Z-2748-2016September 14, 2016Irving, TX
Boston Scientific Corporation
Class IITerminated
Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and tr...
Reason: Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This alternate configuration did not...
Z-2749-2016September 14, 2016Saint Paul, MN
Mentor Texas, LP.
Class IITerminated
MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended f...
Reason: Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Z-2747-2016September 14, 2016Irving, TX
Anthogyr
Class IITerminated
Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of ...
Reason: Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Z-2753-2016September 14, 2016Sallanches
Biomet Microfixation, LLC
Class IITerminated
Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/...
Reason: Potential sterility deficiency.
Z-2751-2016September 14, 2016Jacksonville, FL
Anthogyr
Class IITerminated
Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of...
Reason: Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Z-2754-2016September 14, 2016Sallanches
Alcon Research, Ltd.
Class IITerminated
Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the ...
Reason: The ULTRASERT Delivery System from certain lots have an inferior surface characteristic that could result in the IOL becoming lodged in the Delivery System
Z-2708-2016September 7, 2016Fort Worth, TX
Nakanishi Inc.
Class IITerminated
Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the parent device. For the VarioSurg, in additio...
Reason: Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that...
Z-2673-2016September 7, 2016Kanuma, N/A
Merz North America, Inc.
Class IITerminated
Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe...
Reason: Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Z-2607-2016August 31, 2016Raleigh, NC
Medtronic Inc., Cardiac Rhythm and Heart Failure
Class IITerminated
Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4 Product Usage: The ...
Reason: 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing wi...
Z-2651-2016August 31, 2016Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure
Class IITerminated
Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtroni...
Reason: 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing wi...
Z-2650-2016August 31, 2016Mounds View, MN
Medtronic Neuromodulation
Class IITerminated
DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The ...
Reason: Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Model 64001 and Model 64002, a safety notification was sent to healthcare professional...
Z-2645-2016August 31, 2016Minneapolis, MN
Biomet 3i, LLC
Class IITerminated
Standard Abutment Pick -Up Coping Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2444-2016August 24, 2016Palm Beach Gardens, FL
Biomet 3i, LLC
Class IITerminated
Prep-tite Cap Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2438-2016August 24, 2016Palm Beach Gardens, FL
Biomet 3i, LLC
Class IITerminated
IOL Transfer Impression Coping Dental implants
Reason: Pouches may not have been sealed during packing.
Z-2479-2016August 24, 2016Palm Beach Gardens, FL
Biomet 3i, LLC
Class IITerminated
Gold -Tite Hexed Retaining Screw Dental implants
Reason: Pouches may not have been sealed during packing.