Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen
105 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen
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implantcast GmbH, FSCA_24001, IFU . OPT. MUTARS RS stems and extension pieces
As part of the certification of the MUTARS RS revision system in accordance with the new European regulation MDR (EU) 2017/745, ...
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Waldemar Link GmbH Co.KG, BiMobile Dual Mobility System, Liner
On the affected labels of the BiMobile Liner there is an incorrect letter “F” referring to the compatible size of the MobileLink ...
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DePuy Orthopaedics FA 2113289 - MODULAR CATHCART UNIPOLAR HEAD
Tijdens een interne beoordeling werd vastgesteld dat de Cathcart-kop een offset van +5 mm heeft, wat niet was gespecificeerd in ...
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Stryker RA2022-2911584 - Biolox® Delta Ceramic V40™ Femoral Head - update 16-3-2022
Stryker initiated an urgent, voluntary, lot-specific recall for the Biolox® delta Ceramic V40™ Femoral Head referenced above in ...
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Zimmer Biomet ZFA 2020-00026 - StageOne (Select) Bone Cement Spacer Molds
As a precautionary measure Zimmer Orthopedics is conducting a medical device Field Safety Corrective Action (removal) for ...
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Intuitive Surgical, Inc., ISIFA2022-14-C, da Vinci Xi and da Vinci X Surgical System
Deze veiligheidsmededeling is bedoeld om u erop te wijzen dat een deel van de instrumentarmen (USM's) van het da Vinci X- en Xi ...
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Waldemar Link GmbH and Co.KG, R-204-032, SPII Model Lubinus - Hip Prosthesis Stem
Due to two complaints it has come to our attention, that the SPII Model Lubinus label may be misinterpreted during surgery.
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Xtant Medical Holdings, 3005031160-01/10/2022-001-R, Axle Interspinous Fusion System
Xtant recently became aware that certain implants in the Axle® lnterspinous Fusion System have been manufactured out of ...
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DePuy Ireland FA 2044436 - GLOBAL UNITE STEM
Het betreffende product wordt verwijderd omdat DePuy (Ierland) heeft vastgesteld dat veel Global UNITE-stelen een ondermaatse ...
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Zimmer GmbH, FSN-ZFA 2020-00041, Anaverse Glenoid Liner (XS,S,M,L)
Zimmer GmbH is conducting a medical device Field Safety Corrective Action (Removal) for Anaverse Glenoid Polyethylene (PE) Liner ...