Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2665-2018August 15, 2018Mahwah, NJ
Howmedica Osteonics Corp.
Class IITerminated
rHead Recon Extended Stem Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2708-2018August 15, 2018Mahwah, NJ
Howmedica Osteonics Corp.
Class IITerminated
radial stem implant #1 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2725-2018August 15, 2018Mahwah, NJ
Howmedica Osteonics Corp.
Class IITerminated
radial stem implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2727-2018August 15, 2018Mahwah, NJ
Howmedica Osteonics Corp.
Class IITerminated
radial stem implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Reason: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Z-2728-2018August 15, 2018Mahwah, NJ
Envoy Medical Corporation
Class IITerminated
Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.
Reason: Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. The Sterile Wipes expired prior...
Z-2590-2018August 8, 2018Saint Paul, MN
Howmedica Osteonics Corp.
Class IITerminated
Custom Made Implant System with Minimum Invasive Grower (MIG) component
Reason: From March 2007 to October 2014, product did not contain updated instructions for use (IFU) to clarify the function of locking mechanism and warnings related to the locking screw.
Z-2567-2018August 8, 2018Mahwah, NJ
Philips Healthcare
Class IITerminated
UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications includin...
Reason: The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had...
Z-2499-2018August 1, 2018Andover, MA
Philips Healthcare
Class IITerminated
Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications i...
Reason: The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had...
Z-2498-2018August 1, 2018Andover, MA
Nobel Biocare Usa Llc
Class IITerminated
Nobel Biocare 17¿ Multi-Unit Abutment, Conical Connection NP, 2.5mm, REF 36614. Product Usage: Intended to be used in the upper and lower jaw and used for supporting tooth replacements to restore c...
Reason: The product label has missing information, such as the lot number and expiration date, as well as other information.
Z-2529-2018August 1, 2018Yorba Linda, CA
IMPLANTCAST GMBH
Class IITerminated
2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip implant acetabular component. Size 38/39 mm REF number 02423839 Size 42/44 mm REF number 02424244 Size 44/48 mm REF number 024...
Reason: Possibility that the retaining ring in the 2M inlay 15degree for MUTARS RS Cup and LUMiC TiN is incorrectly mounted.
Z-2517-2018August 1, 2018Buxtehude, N/A
Implant Direct Sybron Manufacturing, LLC
Class IITerminated
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support ...
Reason: The main vial label lists the incorrect part number, but the cap label is correct.
Z-2551-2018August 1, 2018Thousand Oaks, CA
Philips Healthcare
Class IITerminated
Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invasive procedures. Cardiac imaging applications inclu...
Reason: The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had...
Z-2500-2018August 1, 2018Andover, MA
OMNIlife science Inc.
Class IITerminated
OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip re...
Reason: The Internal packaging, the pouch and patient labels are improperly labeled.
Z-2540-2018August 1, 2018Raynham, MA
Cayenne Medical Inc.
Class IITerminated
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110;...
Reason: A review of product complaints in 2010 identified a trend for the Coring Removal Drill of premature wear and/or breakage. This recall occurred in 2013.
Z-2548-2018August 1, 2018Scottsdale, AZ
Medtronic Neuromodulation
Class IITerminated
Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A290 Product Usage: The Medtronic Vectris lead kit...
Reason: This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing defect. This could result in diffi...
Z-2432-2018July 25, 2018Minneapolis, MN
Medtronic Neuromodulation
Class IITerminated
Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation l...
Reason: This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing defect. This could result in diffi...
Z-2431-2018July 25, 2018Minneapolis, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IITerminated
Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillatio...
Reason: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they ...
Z-2420-2018July 18, 2018Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IITerminated
Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the pati...
Reason: Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ven...
Z-2412-2018July 18, 2018Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IITerminated
Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the...
Reason: Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ven...
Z-2413-2018July 18, 2018Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IITerminated
Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the...
Reason: Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ven...
Z-2415-2018July 18, 2018Mounds View, MN
Cayenne Medical Inc.
Class IITerminated
AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.
Reason: Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.
Z-2422-2018July 18, 2018Scottsdale, AZ
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IITerminated
Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD pati...
Reason: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they ...
Z-2416-2018July 18, 2018Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IITerminated
Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillatio...
Reason: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they ...
Z-2421-2018July 18, 2018Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IITerminated
Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG Product Usage: The device indicated for use in ICD pati...
Reason: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they ...