Zimmer Biomet, Inc. - BIPOLAR HIP DEVICE - Class 2 Recall
Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various sizes Use of the MultiPolar Bipolar Cup is indicated in: Fracture dislocation of the hip. Elderly, debilitated patients when a total hip replacement is contraindicated. Irreducible fractures in which adequate fixation cannot be obtained. Certain high subcapital fractures and comminuted femoral neck fractures in the aged. Nonunion of femoral neck fractures. Secondary avascular necrosis of the femoral head. Pathological fractures of the femoral neck. Osteoarthritis in which the femoral head is...
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts
Applied Medical Resources Corp - Voyant Open Fusion Device - Class 2 Recall
Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm (EB040) in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The system delivers the energy required to fuse the tissue between the jaws of the device by monitoring voltage and current throughout the seal cycle. The device also features a useractuated blade...
Source: Medical Device Recalls - September 16, 2015 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - Fenestrated Bipolar Forceps - Class 2 Recall
Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428093-12, 428093-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, ...
Source: Medical Device Recalls - September 11, 2015 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - Maryland Bipolar Forceps - Class 2 Recall
Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428080-04, 428080-05. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, mon...
Source: Medical Device Recalls - September 11, 2015 Category: Medical Equipment Source Type: alerts
Biomet, Inc. - Class 3 Recall
Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6AI-4V, Standard Length Porous Plasma Product Usage: Biomet manufactures a variety of shoulder joint replacement prostheses intended for partial or total shoulder joint arthroplasty for use in cemented and uncemented biological fixation applications. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components. Components are available in a variety of designs and size ranges for both primary and revision applications. Specialty components include glenoid screws, centering sleeves, taper adaptors, and bipola...
Source: Medical Device Recalls - June 12, 2015 Category: Medical Equipment Source Type: alerts
ArthroCare Medical Corporation - Coblator II System - Class 2 Recall
Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller, a reusable, non-sterile Power Cord; a reusable, non-sterile Foot Control; a reusable, non-sterile Flow control Valve Unit; a reusable, non-sterile flow control cable; a single use, disposable, sterile Wand. The Coblator II is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (EN...
Source: Medical Device Recalls - March 27, 2015 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - EndoWrist One Vessel Sealer, 8MM, IS4000 - Class 2 Recall
EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 25, 2015 Category: Medical Equipment Source Type: alerts
Intuitive Surgical, Inc. - EndoWrist One Vessel Sealer, IS3000 - Class 2 Recall
EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit the jaws of the instrument. PN 410322-05 (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 25, 2015 Category: Medical Equipment Source Type: alerts
Alcon Research, Ltd. - Bipolar Forceps - Class 2 Recall
Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only LOT 080614-91 2014-08; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only LOT 061814-95 2014-06. Electrosurgical instrument for ophthalmic surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 Category: Medical Equipment Source Type: alerts
Stryker Endoscopy - PKG, BIPOLAR FORCEPS, FENESTRATED - Class 2 Recall
PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 Category: Medical Equipment Source Type: alerts
Stryker Endoscopy - PKG, BIPOLAR FORCEPS, PADDLE - Class 2 Recall
PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080361. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 Category: Medical Equipment Source Type: alerts
Stryker Endoscopy - PKG, BIPOLAR FORCEPS, FENESTRATED - Class 2 Recall
PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080360. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 Category: Medical Equipment Source Type: alerts
Stryker Endoscopy - PKG, BIPOLAR FORCEPS, MICRO TIP - Class 2 Recall
PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080362. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 Category: Medical Equipment Source Type: alerts
Stryker Endoscopy - PKG, BIPOLAR FORCEPS, FENESTRATED - Class 2 Recall
PKG, BIPOLAR FORCEPS, FENESTRATED 45CM, P/N 0250080113. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 Category: Medical Equipment Source Type: alerts
Stryker Endoscopy - PKG, BIPOLAR FORCEPS, MICRO TIP - Class 2 Recall
PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 Category: Medical Equipment Source Type: alerts
