Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hi...
Reason: Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a packaging associated with a ci...
Z-1317-2014April 9, 2014Mahwah, NJ
Thoratec Corporation
Class ITerminated
HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body whe...
Reason: Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket Sy...
Z-1227-2014April 2, 2014Pleasanton, CA
Thoratec Corporation
Class ITerminated
HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is so...
Reason: Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket Sy...
Z-1228-2014April 2, 2014Pleasanton, CA
Bard Access Systems
Class IITerminated
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
Reason: Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPo...
Z-1300-2014April 2, 2014Salt Lake City, UT
Teleflex Medical
Class IITerminated
Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that con...
Reason: The products are being recalled because they did not meet minimum needle attachment strength requirements.
Z-1295-2014April 2, 2014Research Triangle Park, NC
Biomet 3i, LLC
Class IITerminated
Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Ab...
Reason: Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.
Z-1215-2014March 26, 2014Palm Beach Gardens, FL
Atricure Inc
Class IITerminated
Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA ...
Reason: The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
Z-1209-2014March 26, 2014West Chester, OH
Biomet 3i, LLC
Class IIITerminated
ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trau...
Reason: Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.
Z-1233-2014March 26, 2014Palm Beach Gardens, FL
Synthes, Inc.
Class IITerminated
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commerc...
Reason: Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine ap...
Z-1174-2014March 19, 2014West Chester, PA
AMO Puerto Rico Manufacturing, Inc.
Class IITerminated
AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for the visual correction of aphakia in adult patients.
Reason: Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.
Reason: Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004. Greatbatch has identified th...
Z-1119-2014March 12, 2014Minneapolis, MN
Mako Surgical Corporation
Class IITerminated
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system ...
Reason: The product may be mislabeled and could result in the incorrect implant being used.
Z-1132-2014March 12, 2014Plantation, FL
Medtronic Vascular
Class IIITerminated
Medtronic Everest 20cc Inflation Device; Model Number and Catalog Number: AC2205P The Everest 20cc Inflation device is designed to be used to inflate / deflate balloon catheters as well as to monit...
Reason: Incorrect master label.
Z-1121-2014March 5, 2014Danvers, MA
Orthofix, Inc
Class IITerminated
Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for ...
Reason: There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.
Z-1089-2014March 5, 2014Lewisville, TX
DePuy Orthopaedics, Inc.
Class IITerminated
PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
Reason: Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fati...
Z-1077-2014March 5, 2014Warsaw, IN
Stryker Spine
Class IITerminated
Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Pe...
Reason: Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter.
Z-1086-2014March 5, 2014Allendale, NJ
Implantech Associates Inc
Class IITerminated
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary.
Reason: Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro ...
Z-1063-2014February 26, 2014Ventura, CA
Bausch & Lomb Surgical, Inc.
Class IITerminated
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a catar...
Reason: Lens was manufactured with incorrect raw material.
Z-1062-2014February 26, 2014Clearwater, FL
BioHorizons Implant Systems Inc
Class IITerminated
External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
Reason: The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
Z-1058-2014February 26, 2014Birmingham, AL
Integra LifeSciences Corp.
Class IITerminated
Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. 510(k): 91-2109 K061342. 91-2110 K051942. The Malibu" System...
Reason: Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None ...
Z-0938-2014February 19, 2014Plainsboro, NJ
Stryker Howmedica Osteonics Corp.
Class IITerminated
Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for e...
Reason: Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital.
Z-0975-2014February 19, 2014Mahwah, NJ
Zest Anchors LLC
Class IITerminated
LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed ...
Reason: Zest Anchors, LLC is voluntarily recalling specific lots of LOCATOR¿ Implant Attachment Systems because it is currently provided with a label that indicates that the final torque ...
Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
Reason: Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with the Mosaic Porcine Aortic Bioprosthesis, Model Number 305, because of higher-than-ex...
Z-0908-2014February 12, 2014Santa Ana, CA
Edwards Lifesciences, LLC
Class IITerminated
Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
Reason: Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open ...
Z-0918-2014February 12, 2014Draper, UT
Codman & Shurtleff, Inc.
Class IITerminated
Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The CODMAN CERTAS Programmable Valve i...
Reason: Codman Certas Programmable Valves used for hydrocephalus may not operate properly