Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1306-2020February 26, 2020Yorba Linda, CA
Abbott Vascular
Class ITerminated
NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion ...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1136-2020February 26, 2020Temecula, CA
Nobel Biocare Usa Llc
Class IITerminated
Dense Bone Drill 6.0 6x16 mm Single-Pat- Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1304-2020February 26, 2020Yorba Linda, CA
Nobel Biocare Usa Llc
Class IITerminated
Drill Tapered NP 3.5x8 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1303-2020February 26, 2020Yorba Linda, CA
Abbott Vascular
Class ITerminated
NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1134-2020February 26, 2020Temecula, CA
Nobel Biocare Usa Llc
Class IITerminated
Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical conne...
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1318-2020February 26, 2020Yorba Linda, CA
Nobel Biocare Usa Llc
Class IITerminated
Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with inter...
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1320-2020February 26, 2020Yorba Linda, CA
Nobel Biocare Usa Llc
Class IITerminated
Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal ...
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1317-2020February 26, 2020Yorba Linda, CA
Nobel Biocare Usa Llc
Class IITerminated
Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1311-2020February 26, 2020Yorba Linda, CA
Abbott Vascular
Class ITerminated
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion o...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1133-2020February 26, 2020Temecula, CA
Nobel Biocare Usa Llc
Class IITerminated
Screw Tap Tapered WP Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1305-2020February 26, 2020Yorba Linda, CA
Nobel Biocare Usa Llc
Class IITerminated
Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal c...
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1316-2020February 26, 2020Yorba Linda, CA
Abbott Vascular
Class ITerminated
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion ...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1132-2020February 26, 2020Temecula, CA
Nobel Biocare Usa Llc
Class IITerminated
Drill Tapered RP 4.3x13 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1310-2020February 26, 2020Yorba Linda, CA
Abbott Vascular
Class ITerminated
NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1137-2020February 26, 2020Temecula, CA
Abbott Vascular
Class ITerminated
NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1135-2020February 26, 2020Temecula, CA
Abbott Vascular
Class ITerminated
NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion...
Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1131-2020February 26, 2020Temecula, CA
Nobel Biocare Usa Llc
Class IITerminated
Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1314-2020February 26, 2020Yorba Linda, CA
Nobel Biocare Usa Llc
Class IITerminated
Drill Tapered RP 4.3x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1308-2020February 26, 2020Yorba Linda, CA
Nobel Biocare Usa Llc
Class IITerminated
Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant s...
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1322-2020February 26, 2020Yorba Linda, CA
Nobel Biocare Usa Llc
Class IITerminated
Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall r...
Z-1307-2020February 26, 2020Yorba Linda, CA
Microvention, Inc.
Class IITerminated
Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo...
Reason: The devices may be missing the implant coil.
Z-1224-2020February 19, 2020Aliso Viejo, CA
Flowonix Medical Inc
Class IIOngoing
Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
Reason: A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm ton...
Z-1120-2020February 19, 2020Mansfield, MA
Implant Direct Sybron Manufacturing LLC
Class IITerminated
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
Reason: Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay...