Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, t...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0713-2016February 10, 2016Andover, MA
Philips Electronics North America Corporation
Class IITerminated
Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent pla...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0704-2016February 10, 2016Andover, MA
Philips Electronics North America Corporation
Class IITerminated
Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qua...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0715-2016February 10, 2016Andover, MA
Philips Electronics North America Corporation
Class IITerminated
UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventi...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0708-2016February 10, 2016Andover, MA
Philips Electronics North America Corporation
Class IITerminated
Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. pe...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0712-2016February 10, 2016Andover, MA
Philips Electronics North America Corporation
Class IITerminated
Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab techni...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0716-2016February 10, 2016Andover, MA
Philips Electronics North America Corporation
Class IITerminated
Allura Xper FD20 OR Table; Model Numbers: 722035 722023 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0710-2016February 10, 2016Andover, MA
Philips Electronics North America Corporation
Class IITerminated
Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, t...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0705-2016February 10, 2016Andover, MA
Philips Electronics North America Corporation
Class IITerminated
Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peri...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0711-2016February 10, 2016Andover, MA
Philips Electronics North America Corporation
Class IITerminated
UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, int...
Reason: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
Z-0709-2016February 10, 2016Andover, MA
St Jude Medical Cardiac Rhythm Management Division
Class ITerminated
Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrilla...
Reason: Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil.
Z-0660-2016January 27, 2016Sylmar, CA
Innovasis, Inc
Class IITerminated
Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilizatio...
Reason: Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
Z-0662-2016January 27, 2016Salt Lake City, UT
Abeon Medical Corporation
Class IITerminated
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure.
Reason: The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Z-0686-2016January 27, 2016Brecksville, OH
Zimmer Biomet, Inc.
Class IITerminated
Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Nu...
Reason: Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can inte...
Z-0625-2016January 20, 2016Warsaw, IN
Biomet 3i, LLC
Class IITerminated
BIOMET 3i, PROVIDE IMPRESSION COPING KITS, Catalog # PRK484, PRK485, PRK654, and PRK655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placem...
Reason: Inadequate biocompatibility testing.
Z-0594-2016January 13, 2016Palm Beach Gardens, FL
Zimmer Manufacturing B.V.
Class IITerminated
NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthe...
Reason: A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 was opened for use and the contents were a non-augmented Stemmed Tibia Plate size 3...
BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in th...
Reason: Inadequate biocompatibility testing.
Z-0591-2016January 13, 2016Palm Beach Gardens, FL
Boston Scientific Corporation
Class IITerminated
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead De...
Reason: Potential for separation of the proximal handle from the shaft.
Z-0588-2016January 13, 2016Saint Paul, MN
Biomet 3i, LLC
Class IITerminated
BIOMET 3i, PROVIDE IMPRESSION COPINGS, Catalog # PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, and PIC655H BIOMET 3i Restorative Products are intended for use as an accessory to endoss...
Reason: Inadequate biocompatibility testing.
Z-0593-2016January 13, 2016Palm Beach Gardens, FL
Smith & Nephew, Inc.
Class IITerminated
Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.
Reason: One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning wi...
Z-0573-2016January 13, 2016Memphis, TN
Biomet 3i, LLC
Class IITerminated
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
Reason: Images contained within radiographic transparency ART 1036 are undersized.
Z-0564-2016January 6, 2016Palm Beach Gardens, FL
Aesculap, Inc.
Class IITerminated
Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
Reason: The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patien...
Z-0424-2016December 30, 2015Center Valley, PA
Aesculap, Inc.
Class IITerminated
Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These in...
Reason: The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patien...
Z-0448-2016December 30, 2015Center Valley, PA
Aesculap, Inc.
Class IITerminated
Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
Reason: The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patien...