Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty
Reason: Knee implant components (tibial bearings) are labeled with the incorrect size.
Z-0673-2018February 28, 2018Warsaw, IN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class ITerminated
Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Ev...
Reason: Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Z-0585-2018February 28, 2018Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class ITerminated
Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: b. Visia AF" VR ICD DF4 (Product No. DVAB1D4) Implantable ...
Reason: Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Z-0589-2018February 28, 2018Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class ITerminated
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ...
Reason: Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Z-0583-2018February 28, 2018Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class ITerminated
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1)...
Reason: Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Z-0582-2018February 28, 2018Mounds View, MN
Zimmer Biomet, Inc.
Class IITerminated
Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty
Reason: Knee implant components (tibial bearings) are labeled with the incorrect size.
Z-0674-2018February 28, 2018Warsaw, IN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class ITerminated
Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No. DVFB1D1); b. Visia AF MRI VR SureScan ICD DF4 (Product No....
Reason: Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Z-0588-2018February 28, 2018Mounds View, MN
Oculus Optikgeraete GMBH
Class IITerminated
OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to ...
Reason: The device software versions have an anomaly which may produce an erroneous marking for the quality specification value
Z-0635-2018February 28, 2018Wetzlar, N/A
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class ITerminated
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c....
Reason: Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Z-0584-2018February 28, 2018Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class ITerminated
Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4...
Reason: Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Z-0587-2018February 28, 2018Mounds View, MN
Aesculap Implant Systems LLC
Class IITerminated
ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D1.0 ELAN 4 1-RING ROSENBURR+ D1.0 ELAN 4 1-RING ROSEN BURR D1...
Reason: ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
Z-0619-2018February 21, 2018Center Valley, PA
Aesculap Implant Systems LLC
Class IITerminated
ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL D1,0/4,0MM ELAN 4 2-RING TWIST DRILL D1,1/4,0MM ELAN 4 2-RING TWIST DRILL D1,2/4,0MM ELAN 4 2...
Reason: ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
Z-0620-2018February 21, 2018Center Valley, PA
Aesculap Implant Systems LLC
Class IITerminated
JS Series SterilContainer S2 System
Reason: The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted b...
Z-0624-2018February 21, 2018Center Valley, PA
Aesculap Implant Systems LLC
Class IITerminated
NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is use...
Reason: The NS357R Vega PS Tibia Trial/Preparation Plateau size T4 may be incorrectly labeled. If the incorrect size trial is used the potential risk is implantation of the incorrect impl...
Z-0591-2018February 21, 2018Center Valley, PA
ConforMIS, Inc.
Class IITerminated
Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients ...
Reason: Implant kit mislabeled
Z-0600-2018February 21, 2018Bedford, MA
Aesculap Implant Systems LLC
Class IITerminated
ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 ELAN 4 1-RING NEURO CUTTER SOFT D3.0 ...
Reason: ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
Z-0621-2018February 21, 2018Center Valley, PA
Keystone Dental Inc
Class IITerminated
Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or mu...
Reason: Abutments are unable to accept the final abutment screw
Z-0608-2018February 21, 2018Burlington, MA
Aesculap Implant Systems LLC
Class IITerminated
The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
Reason: The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States (OUS).
Z-0623-2018February 21, 2018Center Valley, PA
Zimmer Biomet, Inc.
Class IITerminated
Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee comp...
Reason: Potential for the Persona Partial Knee Impactor Pad to fracture.
Reason: The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip.
Z-0533-2018February 14, 2018Harleysville, PA
Zimmer Biomet, Inc.
Class IITerminated
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 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-0550-2018February 14, 2018Warsaw, IN
Exactech, Inc.
Class IITerminated
Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surg...
Reason: Wrong device description of the label identifying the implant
Z-0538-2018February 14, 2018Gainesville, FL
Zimmer Biomet, Inc.
Class IITerminated
Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary...
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-0549-2018February 14, 2018Warsaw, IN
Implant Direct Sybron Manufacturing, LLC
Class IITerminated
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Reason: InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
Reason: There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the cathe...