Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IITerminated
MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
Reason: The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. ...
Z-0796-2019February 13, 2019Mounds View, MN
Ascension Orthopedics, Inc
Class IIITerminated
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Reason: The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
Z-0794-2019February 13, 2019Austin, TX
XTANT MEDICAL INC
Class IITerminated
Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8m...
Reason: This recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration...
Z-0790-2019February 6, 2019Belgrade, MT
Waldemar Link GmbH & Co. KG (Mfg Site)
Class IITerminated
BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cann...
Reason: The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
Z-0728-2019January 23, 2019Norderstedt
Zimmer Biomet, Inc.
Class IITerminated
Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilizat...
Reason: There is a potential for silicone shedding during cleaning and sterilization.
Z-0734-2019January 23, 2019Warsaw, IN
Waldemar Link GmbH & Co. KG (Mfg Site)
Class IITerminated
BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cann...
Reason: The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
Z-0729-2019January 23, 2019Norderstedt
Zimmer Biomet, Inc.
Class IITerminated
Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and steriliz...
Reason: There is a potential for silicone shedding during cleaning and sterilization.
Z-0735-2019January 23, 2019Warsaw, IN
Mazor Robotics Ltd
Class IITerminated
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instrume...
Reason: In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.
Z-0609-2019December 26, 2018North Industrial Park
Bausch & Lomb Surgical, Inc.
Class IITerminated
enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed....
Reason: Cosmetic imperfections on the surface of some lenses.
Z-0628-2019December 26, 2018Clearwater, FL
St. Jude Medical, Inc.
Class IITerminated
St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano, TX St. Jude Medical InfinityTM DBS System 8CH Direction...
Reason: The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium.
Z-0593-2019December 19, 2018Plano, TX
Neotract Inc
Class IITerminated
UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract
Reason: Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mode, the needle is deployed into the prostate and retracted, leaving no...
Z-0598-2019December 19, 2018Pleasanton, CA
Howmedica Osteonics Corp.
Class IITerminated
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
Reason: The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.
Z-0605-2019December 19, 2018Allendale, NJ
Zimmer Biomet, Inc.
Class IITerminated
Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number: 47-2255-008-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of ...
Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Z-0536-2019December 12, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation...
Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Z-0537-2019December 12, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaed...
Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Z-0542-2019December 12, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-038-00 Product Usage: A single use surgical instrument used during orthop...
Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Z-0535-2019December 12, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2490-097-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for...
Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Z-0539-2019December 12, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00 Product Usage: A single use surgical instrument used during orthopaedic surger...
Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Z-0533-2019December 12, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, o...
Reason: Potential metal burrs in the holes of the device preventing the appropriate drill and transverse pins from being inserted
Z-0553-2019December 12, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Product Usage: A single use surgical instrument used during ortho...
Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Z-0532-2019December 12, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedi...
Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Z-0530-2019December 12, 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: A single use surgical instrument used during orthopaedic surgery for ...
Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Z-0541-2019December 12, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product Usage: A single use surgical instrument used during orthopaedi...
Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Z-0531-2019December 12, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2490-097-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for...
Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Z-0538-2019December 12, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Product Usage: A single use surgical instrument used during orthopaedic surger...
Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility