Reason: There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to be replaced causing the wound...
Z-0316-2017November 2, 2016Center Valley, PA
St Jude Medical Inc.
Class ITerminated
Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD3357-40Q. Fortify and Fortify Assura implantable cardioverter...
Reason: St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature batt...
Z-0116-2017November 2, 2016Sylmar, CA
Keystone Dental Inc
Class IITerminated
Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in ...
Reason: Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
Z-0299-2017November 2, 2016Burlington, MA
St Jude Medical Inc.
Class ITerminated
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillat...
Reason: St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature batt...
Z-0117-2017November 2, 2016Sylmar, CA
Zimmer Biomet, Inc.
Class IITerminated
Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartment...
Reason: Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X ...
Z-0111-2017October 26, 2016Warsaw, IN
X Spine Systems Inc
Class IITerminated
Calix T PEEK Lumbar System, TLIF Trial
Reason: The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral spac...
Z-0127-2017October 26, 2016Miamisburg, OH
X Spine Systems Inc
Class IITerminated
Calix T PEEK Lumbar System, TLIF Rasp
Reason: The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral spac...
Z-0126-2017October 26, 2016Miamisburg, OH
Zimmer Biomet, Inc.
Class IITerminated
Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure...
Reason: The G-PIN 2.8BL 3.2PL 60 CM 2PK is intended to contain one (1) 467265-01 Ball Tip Guide Pin and one (1) 467255-02 Plain Tip Guide Pin. The G-PIN 2.8BL 3.2PL 60 CM 2PK may have been...
Z-0087-2017October 26, 2016Warsaw, IN
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Class IITerminated
RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junc...
Reason: RTI Surgical Inc. (RTI) is conducting a voluntary recall on two specific lots of the Streamline¿ OCT Straight Rod, CoCr. 3.2mm (D) x 240mm (L) due to the potential for small crac...
Z-0290-2017October 26, 2016Marquette, MI
X Spine Systems Inc
Class IITerminated
Calix P PEEK Lumbar System, PLIF Rasp
Reason: The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral spac...
Z-0124-2017October 26, 2016Miamisburg, OH
X Spine Systems Inc
Class IITerminated
Calix P PEEK Lumbar System, PLIF Trial
Reason: The trials and rasps used to prepare the surgical site for placement of the implant may become detached from the inserter assembly part and become lodged in the intervertebral spac...
Z-0125-2017October 26, 2016Miamisburg, OH
Osteogenics Biomedical, Inc.
Class IITerminated
Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.
Reason: The device has the potential to be packaged in the wrong product box.
Z-0113-2017October 26, 2016Lubbock, TX
Zimmer Biomet, Inc.
Class IITerminated
Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implante...
Reason: Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targ...
Z-0083-2017October 19, 2016Warsaw, IN
GE OEC Medical Systems, Inc
Class IITerminated
OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic imag...
Reason: GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls ver...
Z-0071-2017October 19, 2016Salt Lake City, UT
Zimmer Biomet, Inc.
Class IITerminated
Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implanted int...
Reason: Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targ...
Z-0084-2017October 19, 2016Warsaw, IN
Stryker Howmedica Osteonics Corp.
Class IITerminated
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.
Reason: Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner.
Z-0060-2017October 19, 2016Mahwah, NJ
Trimed Inc
Class IITerminated
TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel confor...
Reason: TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted.
Z-2849-2016September 28, 2016Santa Clarita, CA
Abbott Medical Optics Inc. (AMO)
Class IITerminated
TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular catar...
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-2858-2016September 28, 2016Santa Ana, CA
Abbott Medical Optics Inc. (AMO)
Class IITerminated
TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 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-2863-2016September 28, 2016Santa Ana, CA
Abbott Medical Optics Inc. (AMO)
Class IITerminated
TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a...
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-2857-2016September 28, 2016Santa Ana, CA
Abbott Medical Optics Inc. (AMO)
Class IITerminated
SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular catar...
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-2860-2016September 28, 2016Santa Ana, CA
Abbott Medical Optics Inc. (AMO)
Class IITerminated
TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom ...
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-2862-2016September 28, 2016Santa Ana, CA
Biomet 3i, LLC
Class IITerminated
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens h...
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-2864-2016September 28, 2016Santa Ana, CA
Abbott Medical Optics Inc. (AMO)
Class IITerminated
TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataracto...
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.