Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intrave...
Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Z-2189-2014August 20, 2014Raynham, MA
Codman & Shurtleff, Inc.
Class IITerminated
Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure an...
Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Z-2185-2014August 20, 2014Raynham, MA
Codman & Shurtleff, Inc.
Class IITerminated
Codman Certas - In Line Valve only with SIPHONGUARD¿ Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure a...
Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Z-2188-2014August 20, 2014Raynham, MA
Codman & Shurtleff, Inc.
Class IITerminated
Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8807 The Codman Certas Programmable valve is an implantable device that prov...
Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Z-2191-2014August 20, 2014Raynham, MA
Medtronic MiniMed Inc.
Class IITerminated
Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
Reason: Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a pump malfunction resulting in the disconnection of the delivery of insulin prior to...
Z-2173-2014August 20, 2014Northridge, CA
Codman & Shurtleff, Inc.
Class IITerminated
Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pr...
Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Z-2186-2014August 20, 2014Raynham, MA
Codman & Shurtleff, Inc.
Class IITerminated
Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmable valve is an implantable device that provides constant intra...
Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Z-2190-2014August 20, 2014Raynham, MA
Codman & Shurtleff, Inc.
Class IITerminated
Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebr...
Reason: To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Z-2184-2014August 20, 2014Raynham, MA
Medtronic Neuromodulation
Class IITerminated
Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The Ascenda Intrathecal Catheter is part of an infusion system...
Reason: Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which are used with the implantable SynchroMed drug infusion pump. This recall is being...
Z-2172-2014August 20, 2014Minneapolis, MN
Zimmer, Inc.
Class IITerminated
Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Dental implant component.
Reason: Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."
Z-2144-2014August 13, 2014Warsaw, IN
Boston Scientific CRM Corp
Class IITerminated
Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver card...
Reason: A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results we...
Z-2147-2014August 13, 2014Saint Paul, MN
Baxter Healthcare Corporation
Class IITerminated
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstr...
Reason: Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and po...
Z-2126-2014August 6, 2014Westlake Village, CA
Small Bone Innovations
Class IITerminated
Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of ...
Reason: Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU.
Z-2127-2014August 6, 2014Morrisville, PA
Medtronic Neuromodulation
Class IITerminated
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and im...
Reason: Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth.
Z-2118-2014August 6, 2014Minneapolis, MN
Exactech, Inc.
Class IITerminated
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
Reason: The femoral stem is lacking specified plasma coating.
Z-2086-2014July 30, 2014Gainesville, FL
Zimmer, Inc.
Class IITerminated
Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
Reason: Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap ...
Z-2050-2014July 23, 2014Warsaw, IN
Innovasis, Inc
Class IITerminated
Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as...
Reason: Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
Z-2067-2014July 23, 2014Salt Lake City, UT
Zimmer, Inc.
Class IITerminated
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an aceta...
Reason: Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
Z-2035-2014July 16, 2014Warsaw, IN
Zimmer, Inc.
Class IITerminated
Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular ...
Reason: Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
Z-2033-2014July 16, 2014Warsaw, IN
Zimmer, Inc.
Class IITerminated
Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetab...
Reason: Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
Z-2034-2014July 16, 2014Warsaw, IN
Stryker Howmedica Osteonics Corp.
Class IITerminated
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to ...
Reason: Tritanium Patella Inserter Instrument fracture during implantation. .
Reason: Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left ...
Z-1943-2014July 9, 2014Plymouth, MN
SeaSpine Inc
Class IITerminated
Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, a...
Reason: Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to...
Z-1841-2014July 2, 2014Vista, CA
Biomet, Inc.
Class IITerminated
DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthrop...
Reason: Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience ...