ARCHIBONE (rheumatoid arthritis and osteoarthritis recovery, and cartilage restore) capsule [HCBIOPHARM LLC]
Updated Date: Tue, 26 Dec 2023 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 26, 2023 Category: Drugs & Pharmacology Source Type: alerts
ARCHIBONE (rheumatoid arthritis and osteoarthritis recovery, and cartilage restore) capsule [HCBIOPHARM LLC]
Updated Date: Fri, 30 Dec 2022 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - December 30, 2022 Category: Drugs & Pharmacology Source Type: alerts
RHEUMATOID ARTHRITIS NOSODE (adenosinum triphosphoricum dinatrum, malic acid, natrum oxalaceticum, oroticum acidum, riboflavinum, apiolum, cinnamic acid, dhea (dehydroepiandrosterone), streptococcus viridans, borrelia burgdorferi nosode, brucella abortus, calcarea carbonica, campylobacter jejuni, chlamydia trachomatis, klebsiella pheumoniae, mycoplasma pneumoniae, yersinia enterocolitica, pneumococcinum, streptococcus agalactiae, enterococcus faecalis, streptococcus mutans, salmonella enteritidis, dysentery bacillus, shigella sonnei) liquid [Deseret Biologicals, Inc.]
Updated Date: Fri, 11 Nov 2022 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 11, 2022 Category: Drugs & Pharmacology Source Type: alerts
RHEUMATOID ARTHRITIS NOSODE (atp (adenosine triphosphate disodium), malic acid, natrum oxalaceticum, riboflavinum, apiolum, cinnamic acid, dhea (dehydroepiandrosterone), streptococcus viridans) liquid [Deseret Biologicals, Inc.]
Updated Date: Fri, 11 Nov 2022 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 11, 2022 Category: Drugs & Pharmacology Source Type: alerts
ARCHIBONE (rheumatoid arthritis and osteoarthritis recovery, and cartilage restore) capsule [HCBIOPHARM LLC]
Updated Date: Thu, 18 Aug 2022 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 18, 2022 Category: Drugs & Pharmacology Source Type: alerts
HERBCITI ARCHIBONE (rheumatoid arthritis and osteoarthritis recovery, and cartilage restore) capsule [HerbCiti LLC]
Updated Date: Mon, 22 Nov 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - November 22, 2021 Category: Drugs & Pharmacology Source Type: alerts
Biomet, Inc. - Custom Cancellous Thread - Class 2 Recall
Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 18, 2020 Category: Medical Devices Source Type: alerts
Encore Medical, LP - EMPOWR Acetabular System - Class 2 Recall
EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; rheumatoid arthritis, correction of functional deformity, femoral fracture, and in the salvage of previously failed surgical attempts. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 9, 2020 Category: Medical Devices Source Type: alerts
Integra Lifesciences Sales Llc - Ascension Silicone PIPSilicone - Class 2 Recall
Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 17, 2019 Category: Medical Devices Source Type: alerts
Randox Laboratories Ltd. - Rheumatoid Factor Calibrators - Class 2 Recall
Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syphilis. However, in these conditions the RF titre is much lower than in rheumatoid arthritis. This test kit must be used by suitably q...
Source: Medical Device Recalls - November 5, 2019 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics, Inc - Atellica IM antiCCP IgG (aCCP) Assay - Class 2 Recall
Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur¿ Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma (K2-EDTA, lithium heparin) using the ADVIA Centaur XP system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-crite...
Source: Medical Device Recalls - September 27, 2019 Category: Medical Devices Source Type: alerts
Hycor Biomedical Inc - Autostat II Rheumatoid Factor IgM ELISA - Class 2 Recall
AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR Hy...
Source: Medical Device Recalls - July 31, 2019 Category: Medical Devices Source Type: alerts
Phadia Ab - EliA RF IgM Immunoassay - Class 2 Recall
EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000. (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 2, 2019 Category: Medical Devices Source Type: alerts
Exactech, Inc. - Truliant Tibial Fit Tray - Class 2 Recall
Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 24, 2019 Category: Medical Devices Source Type: alerts
MicroPort Orthopedics Inc. - MicroPort Orthopedics SCHANZ SCREW SELF DRILL - Class 2 Recall
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed (Sour...
Source: Medical Device Recalls - October 12, 2018 Category: Medical Devices Source Type: alerts
