01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are use...
Reason: Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
Z-1885-2017May 3, 2017Marietta, GA
XTANT MEDICAL INC
Class IITerminated
5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an ac...
Reason: The material type on the label may incorrectly state Ti6Al-4V ELI . The rods are composed of Cobalt Chromium.
Z-1884-2017May 3, 2017Belgrade, MT
Zimmer Biomet, Inc.
Class IITerminated
various polyethylene implants Custom parts Product Usage: Custom
Reason: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Z-1862-2017April 26, 2017Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
Reason: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Z-1863-2017April 26, 2017Warsaw, IN
Instradent USA, Inc.
Class IITerminated
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Reason: During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Im...
various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +...
Reason: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Z-1860-2017April 26, 2017Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to b...
Reason: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Z-1858-2017April 26, 2017Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacem...
Reason: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Z-1859-2017April 26, 2017Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim ...
Reason: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Z-1861-2017April 26, 2017Warsaw, IN
Zimmer Dental Inc
Class IITerminated
Tapered SwissPlus Implant System, Model No. SPB10
Reason: It was manufactured with the minor diameter of the internal thread that is below specification.
Z-1823-2017April 26, 2017Carlsbad, CA
Keystone Dental Inc
Class IITerminated
Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the tr...
Reason: Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when r...
Z-1814-2017April 19, 2017Center Valley, PA
Medtronic Neurosurgery
Class ITerminated
The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the periton...
Reason: Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the StrataMR Locator Tool: When the StrataMR valve is set in the incorrect orientation, high...
Z-1702-2017April 19, 2017Goleta, CA
United Orthopedic Corporation
Class IITerminated
UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
Reason: The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.
Z-1692-2017April 5, 2017Hsinchu
Biomet 3i, LLC
Class IITerminated
BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within Tyvek tray within cardboard box; one (1) unit per box. Labeled Sterile"
Reason: A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier
Z-1701-2017April 5, 2017Palm Beach Gardens, FL
Medtronic Neuromodulation
Class IITerminated
SynchroMed II implantable drug infusion pump, Model 8637-40,
Reason: Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error co...
Z-1694-2017April 5, 2017Minneapolis, MN
Medical Components, Inc dba MedComp
Class IITerminated
9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascula...
Reason: The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F va...
Z-1536-2017March 29, 2017Harleysville, PA
Crossroads Extremity Systems Llc
Class IITerminated
MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
Reason: Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.
Z-1487-2017March 29, 2017Memphis, TN
Medtronic Vascular, Inc.
Class IITerminated
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166E ETBF2313C...
Reason: Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific models and serial numbers as this...
Z-1543-2017March 29, 2017Santa Rosa, CA
Kiscomedica S.A.
Class IITerminated
L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally ma...
Reason: Firm received a complaint of the tip holder breaking during use.
Z-1461-2017March 22, 2017Saint Priest, N/A
Inion Ltd.
Class IITerminated
Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tiss...
Reason: Aluminum pouch seal was noticed to be defective (slightly open).
Z-1478-2017March 22, 2017FIN-33520 Tampere, N/A
Medtronic Neuromodulation
Class ITerminated
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implanta...
Reason: Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software applic...
Z-0788-2017March 8, 2017Minneapolis, MN
Encore Medical, Lp
Class IITerminated
LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilize...
Reason: Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, wh...
Z-1191-2017February 22, 2017Austin, TX
Acumed LLC
Class IITerminated
6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and...
Reason: The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium ...