Biomet 3i, LLC - LOW PROFILE ABUTMENTS INTERNAL AND EXTERNAL CONNECTION - Class 2 Recall
BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 21, 2016 Category: Medical Equipment Source Type: alerts
Biomet 3i, LLC - LOW PROFILE ABUTMENTS INTERNAL AND EXTERNAL CONNECTION - Class 2 Recall
BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 21, 2016 Category: Medical Equipment Source Type: alerts
Smith & Nephew, Inc. - REFLECTION Spherical Head Screw - Class 2 Recall
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant; congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, nonunion, fe...
Source: Medical Device Recalls - July 29, 2016 Category: Medical Equipment Source Type: alerts
Zimmer Biomet, Inc. - NATURALKNEE II SYSTEM - Class 2 Recall
NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou sizes Product Usage "" The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). " The Natural-Knee II primary components without CSTi Porous Coating, all ...
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts
Zimmer Biomet, Inc. - GENDER SOLUTIONS NATURALKNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CRFLEX GENDER SOLUTIONS F - Class 2 Recall
CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). " Components without CSTi porous coating are indicated for c...
Source: Medical Device Recalls - February 23, 2016 Category: Medical Equipment Source Type: alerts
Winco Mfg., LLC - Winco XL Convalescent Recliner with Steel Casters - Class 2 Recall
Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement facilities) (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 15, 2015 Category: Medical Equipment Source Type: alerts
BTE Technologies, Inc. - Primus (THE BTE WS30) - Class 2 Recall
Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 7, 2015 Category: Medical Equipment Source Type: alerts
International Rehabilitative Sciences, Inc. - RSFBG Full Back Conductive Garment - Class 2 Recall
The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with interferential and muscle stimulation with a Transcutaneous Electrical Nerve Stimulation device (TENS) and/or muscle stimulator. The RS-FBG is a prescription device for use with RS Medical Stimulators to facilitate electrode placement and maintenance of electrode positioning for stimulation treatments. The device is sold individually in several variations for size. It is fitted to the patient and an RS Medical employee gives the patient instructions on how to utilize the device with proper electrode placement in conjunction with ...
Source: Medical Device Recalls - June 27, 2015 Category: Medical Equipment Source Type: alerts
Zimmer Gmbh - Class 2 Recall
CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 21, 2015 Category: Medical Equipment Source Type: alerts
Zimmer Manufacturing B.V. - Trilogy Cups - Class 2 Recall
Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 25, 2014 Category: Medical Equipment Source Type: alerts
Zimmer Manufacturing B.V. - Trilogy Bone Screws - Class 2 Recall
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-holed shells allow for the use of screws to provide additional fixation and security, particularly in those case where acetabular bone stock is deficient. The Trilogy Acetabular System is indicated for either cemented or uncemented use in skeletally mature individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, ...
Source: Medical Device Recalls - December 18, 2014 Category: Medical Equipment Source Type: alerts
GF Health Products, Inc./d.b.a.Basic American Metal Products - Zenith Slide WIDE Long Term Care Bed - Class 2 Recall
Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.). (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 17, 2014 Category: Medical Equipment Source Type: alerts
Shape Medical Systems, Inc - Shape HF Cardiopulmonary System - Class 2 Recall
Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). The Shape-HF Cardiopulmonary Testing System is a cardiopulmonary gas exchange testing system intended for used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in their patient assessment. The Shape-HF Cardiopulmonary Testing System is a pulmonary function stationary testing system intended to be used to monitor cardiopulmonary functions during stress tes...
Source: Medical Device Recalls - July 15, 2014 Category: Medical Equipment Source Type: alerts
Zynex Medical, Inc. - IF 8000 - Class 2 Recall
IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2014 Category: Medical Equipment Source Type: alerts
Zimmer, Inc. - DROP LOK Knee Brace - Class 2 Recall
DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or following surgical correction. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 11, 2014 Category: Medical Equipment Source Type: alerts
