Zimmer Biomet reveals FDA warning letter

Zimmer Biomet (NYSE:ZBH) today revealed a warning letter it received in late may over non-conformities with good manufacturing practice requirements for its quality system regulation at its Montreal, Quebec facilities. The letter, which came based on a January inspection of the company’s facilities, restricts the clearance of premarket approval applications for Class III devices which are affected by the quality system regulation deviations. The company said that it has no such applications. The letter “does not restrict production or shipment” of goods from the Montreal facility, nor does it require any withdrawal of any current products from the market, according to an SEC filing from the company. Zimmer Biomet said it has “provided detailed responses to the FDA” explaining the corrective actions it took, and added that it believes the warning letter can be “resolved without a material impact on the company’s financial results.” A definitive response from the FDA could not be guaranteed, and the company warned that until the violations are corrected, it “may be subject to additional regulatory action by the FDA.” Last month, Zimmer Biomet said it closed its buyout of Cayenne Medical and its soft tissue reconstruction devices for an unspecified amount. Scottsdale, Ariz.-based Cayenne makes devices for knee and shoulder repair, including the AperFix II, CrossFix II and iFix knee ligament reconstru...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Zimmer Biomet Source Type: news

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Publication date: Available online 12 October 2019Source: Life SciencesAuthor(s): Liang Qiao, Yan Kong, Yingshen Shi, Aijun Sun, Ruijuan Ji, Chao Huang, Yuquan Li, Xiangqun YangAbstractAimsThe aims of the study are to investigate whether the combination of adipose-derived stem cells (ADSCs) with decellularized extracellular matrix (dECM) of myocardium can exert synergistic therapeutic effects on acute MI and the underlying mechanism.Main methodsMyocardial dECM from fresh porcine myocardium was prepared in an injectable gel, ADSCs were seeded into the myocardial dECM gels, and then the mixture was injected into the myocardi...
Source: Life Sciences - Category: Biology Source Type: research
This study was carried out to elucidate the antineoplastic effect of quercetin through regulating both Notch and Hh pathways, apoptosis, cell proliferation and CK2α activity.Main methodsHepatocellular carcinoma was induced in male Sprague Dawley rats by thioacetamide. Quercetin was administered in both protective and curative doses. Parameters of liver function and oxidative stress were assessed. CK2α, Notch and Hh pathways were evaluated using RT-PCR and ELISA. Apoptosis was investigated by detecting caspase-3, caspase-8 and p53. Proliferative and cell cycle markers as cyclin D1 and Ki-67 were detected immunoh...
Source: Life Sciences - Category: Biology Source Type: research
Publication date: Available online 11 October 2019Source: Advances in Biological RegulationAuthor(s): Raymond D. BlindAbstract:The higher-order inositol phosphate second messengers inositol tetrakisphosphate (IP4), inositol pentakisphosphate (IP5) and inositol hexakisphosphate (IP6) are important signaling molecules that regulate DNA-damage repair, cohesin dynamics, RNA-editing, retroviral assembly, nuclear transport, phosphorylation, acetylation, crotonylation, and ubiquitination. This functional diversity has made understanding how inositol polyphosphates regulate cellular processes challenging to dissect. However, some ...
Source: Advances in Biological Regulation - Category: Biology Source Type: research
ConclusionsThe use of CST in the face of contamination is not associated with an increase in wound complications, mesh complications, or recurrence.
Source: The American Journal of Surgery - Category: Surgery Source Type: research
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Source: Arthroscopy Techniques - Category: Surgery Source Type: research
Publication date: Available online 11 October 2019Source: Arthroscopy TechniquesAuthor(s): Joseph N. Liu, Troy G. Shields, Anirudh K. Gowd, Nirav H. AminAbstractBone marrow lesions (BMLs) in the knee represent focal edema caused by subchondral bone attrition and microfractures to the trabecular bone. These lesions are poor prognostic indicators for several orthopaedic procedures but also have been associated with the progression of osteoarthritis. Current research is aimed at treating BMLs with the intent to improve the overall structural integrity of the subchondral bone and delay the need for arthroplasty. The injection ...
Source: Arthroscopy Techniques - Category: Surgery Source Type: research
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Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
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Source: The American Journal of Surgical Pathology - Category: Pathology Tags: Original Articles Source Type: research
Authors: Debonnaire P, Coussement P, Van der Heyden J PMID: 31599698 [PubMed - as supplied by publisher]
Source: Acta Cardiologica - Category: Cardiology Tags: Acta Cardiol Source Type: research
Purpose of review One of the most vexing problems for gastroenterologists is what actions to take after receiving a histological diagnosis of gastric intestinal metaplasia. We approach the problem by starting with suggesting a biopsy protocol that ensures obtaining the biopsies required for diagnosis, assessing the status of the gastric mucosa, and effective communication with the pathologist and patient. Recent findings The rediscovery and integration of the long history of gastric damage and repair resulting in pseudopyloric metaplasia (called SPEM) into the thinking of investigators working with animal models of ga...
Source: Current Opinion in Gastroenterology - Category: Gastroenterology Tags: STOMACH AND DUODENUM: Edited by Mitchell L. Schubert Source Type: research
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