M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used dur...
Reason: The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new ...
Z-0547-2018February 14, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming...
Reason: The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new ...
Z-0551-2018February 14, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used...
Reason: The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new ...
Z-0548-2018February 14, 2018Warsaw, IN
Medtronic Inc., Cardiac Rhythm and Heart Failure
Class IITerminated
MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted ...
Reason: Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's...
Z-0400-2018January 31, 2018Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure
Class IITerminated
MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implante...
Reason: Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's...
Z-0399-2018January 31, 2018Mounds View, MN
Zoll Manufacturing Corp.
Class IITerminated
LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not...
Reason: Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
Z-0353-2018January 24, 2018Pittsburgh, PA
Encore Medical, Lp
Class IITerminated
EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery.
Reason: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Z-0327-2018January 17, 2018Austin, TX
Encore Medical, Lp
Class IITerminated
DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.
Reason: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Z-0326-2018January 17, 2018Austin, TX
Encore Medical, Lp
Class IITerminated
EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery.
Reason: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Z-0329-2018January 17, 2018Austin, TX
Encore Medical, Lp
Class IITerminated
EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery.
Reason: The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Z-0328-2018January 17, 2018Austin, TX
Zimmer Dental Inc
Class IITerminated
Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseou...
Reason: The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a den...
Z-0281-2018December 27, 2017Carlsbad, CA
C.R. Bard, Inc.
Class IITerminated
I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head ...
Reason: Activity and quantity of seeds sent in shipments were incorrect.
Z-0267-2018December 27, 2017Covington, GA
Zimmer Biomet, Inc.
Class IITerminated
ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be plac...
Reason: Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular Radial HD lock screw was not incl...
Z-0269-2018December 27, 2017Warsaw, IN
Implant Direct Sybron Manufacturing, LLC
Class IITerminated
Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to creat...
Reason: The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians...
Z-0283-2018December 27, 2017Westlake Village, CA
Zimmer Dental Inc
Class IITerminated
Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OPCST. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant acce...
Reason: The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a den...
Z-0280-2018December 27, 2017Carlsbad, CA
Zimmer Dental Inc
Class IITerminated
Tapered Screw-Vent MTX Model TSVTB11
Reason: Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
Z-0284-2018December 27, 2017Carlsbad, CA
Zimmer Dental Inc
Class IITerminated
Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intend...
Reason: The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a den...
Z-0279-2018December 27, 2017Carlsbad, CA
Philips Electronics North America Corporation
Class IITerminated
Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and ne...
Reason: When using the downscale option with the Allura R9 system or Azurion R1.1 system, the measurements performed using the QA Basic Measurement tool will not be correctly exported to t...
Z-0255-2018December 27, 2017Andover, MA
Zimmer Dental Inc
Class IITerminated
Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseo...
Reason: The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a den...
Z-0282-2018December 27, 2017Carlsbad, CA
Implant Direct Sybron Manufacturing, LLC
Class IITerminated
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially a...
Reason: One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide free...
Z-0185-2018December 6, 2017Westlake Village, CA
HILL-ROM MANUFACTURING, INC.
Class IITerminated
Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., ...
Reason: Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subje...
Z-0192-2018December 6, 2017Saint Paul, MN
Smith & Nephew, Inc.
Class IITerminated
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-t...
Reason: The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Z-0092-2018November 22, 2017Memphis, TN
Zimmer Biomet, Inc.
Class IITerminated
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
Reason: A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. After the device was manufactured and used in the planned surge...
Z-0070-2018November 15, 2017Warsaw, IN
Limacorporate S.p.A
Class IICompleted
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Reason: An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical streng...
Z-0068-2018November 15, 2017San Daniele del Friuli, N/A
Encore Medical, Lp
Class IITerminated
EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused ...
Reason: It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.