Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV270, Catalog Number LTV27; Product Usage: The Lotus Valve System is intended t...
Reason: Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If...
Z-0917-2015January 21, 2015Los Gatos, CA
Boston Scientific Corporation
Class ITerminated
Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV250, Catalog Number LTV25; Product Usage: The Lotus Valve System is intended t...
Reason: Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If...
Z-0916-2015January 21, 2015Los Gatos, CA
Boston Scientific Corporation
Class ITerminated
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23; Product Usage: The Lotus Valve System is intended ...
Reason: Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If...
Z-0915-2015January 21, 2015Los Gatos, CA
St Jude Medical Cardiac Rhythm Management Division
Class IITerminated
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
Reason: Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assur...
Z-0949-2015January 21, 2015Sylmar, CA
Straumann USA, LLC
Class IITerminated
Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the de...
Reason: Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
Z-0909-2015January 14, 2015Parsippany, NJ
Zimmer, Inc.
Class IITerminated
Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants.
Reason: Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek lid and cavity when opened for internal bone cement cure and pairing test...
Z-0900-2015January 7, 2015Warsaw, IN
Zimmer, Inc.
Class IITerminated
Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Per...
Reason: The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Zimmer received one complaint indicating the magnet cover ...
Z-0853-2015December 31, 2014Warsaw, IN
Instradent USA, Inc.
Class IITerminated
Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to pr...
Reason: Product not approved for use in the US
Z-0839-2015December 31, 2014Andover, MA
Cyberonics, Inc
Class IITerminated
Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system use...
Reason: The recalled product was distributed with an incorrect serial number printed on the device's label.
Z-0858-2015December 31, 2014Houston, TX
American Medical Systems, Inc.
Class IITerminated
AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVance Male Sling System consists of two, sterile single-use su...
Reason: During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components s...
Z-0806-2015December 24, 2014Minnetonka, MN
Mako Surgical Corporation
Class IITerminated
RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components ...
Reason: MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Z-0828-2015December 24, 2014Plantation, FL
4-Web Inc.
Class IITerminated
ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (ort...
Reason: Product is mislabeled.
Z-0812-2015December 24, 2014Frisco, TX
American Medical Systems, Inc.
Class IITerminated
AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc...
Reason: During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components s...
Z-0805-2015December 24, 2014Minnetonka, MN
Mako Surgical Corporation
Class IITerminated
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup c...
Reason: MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Z-0830-2015December 24, 2014Plantation, FL
Mako Surgical Corporation
Class IITerminated
RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup...
Reason: MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Z-0829-2015December 24, 2014Plantation, FL
Philips Medical Systems (Cleveland) Inc
Class IITerminated
IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model numbe...
Reason: Software defect. In certain circumstances, the application may display incorrect measurements of cardiac and aortic anatomy used to select and size the Transcatheter heart valve (...
Z-0473-2015December 3, 2014Cleveland, OH
Materialise USA LLC
Class IITerminated
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperat...
Reason: The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specif...
Z-0418-2015December 3, 2014Plymouth, MI
Biomet Spine LLC.
Class IITerminated
LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft...
Reason: Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.
Z-0220-2015November 26, 2014Broomfield, CO
Medacta Usa
Class IITerminated
The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
Reason: The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery.
Z-0225-2015November 26, 2014Chicago, IL
Straumann USA, LLC
Class IITerminated
Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibula...
Reason: Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
Z-0174-2015November 12, 2014Andover, MA
Trivascular, Inc
Class ITerminated
Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to...
Reason: TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to...
Z-0125-2015November 12, 2014Santa Rosa, CA
Zimmer Dental Inc
Class IITerminated
Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses ...
Reason: Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
Z-0153-2015November 5, 2014Carlsbad, CA
Zimmer Dental Inc
Class IITerminated
Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform Part No. TSV4B11 The Tapered Screw-Vent Imp...
Reason: Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.