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…MHRA is updating advice provided in MDA/2012/036, to assist the early detection of soft tissue reactions in patients implanted with metal-on-metal (MoM) hip replacements (MDA/2017/018)…
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…[Archived] (All) MHRA issues updated information and advice for the follow-ups of patients implanted with metal-on-metal (MoM) hip replacements. (MDA/2012/036)…
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…[Archived] (Smith & Nephew Orthopaedics) Birmingham Hip™ Resurfacing (BHR) system - higher than expected revision rate for certain patient groups (MDA/2015/024)…
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Summary List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 August 2017
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A list of all medical device alerts that were archived in May 2015.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 11 - 15 July 2016
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Summary List of field safety notices (FSNs) from medical device manufacturers from 13 February - 17 February 2017
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(Waldemar Link GmbH & Company.KG) Consider annual review of patients for up to 5 years after implantation, including X-rays to detect progression of bearing wear. (MDA/2014/018)
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List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 January 2015.
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List of Field Safety Notices from 28 October to 1 November 2024
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 - 27 May 2016
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…Winthrop Pharmaceuticals UK Limited (trading as Zentiva) is conducting a precautionary recall of a single batch of Molipaxin 100 mg capsules due to a potential issue with the metal detector during manufacture of the batch (EL(18) A/01).…
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Bristol Laboratories Ltd. are recalling one batch of Phenobarbital Bristol Labs 15mg Tablets as a precautionary measure due to the potential of contamination of small metallic particles within the tablets.
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…Recent research has found that the CPT Hip System Femoral Stem 12/14 Neck Taper, cobalt chromium, (a type of hip implant) carries a higher risk of postoperative periprosthetic femoral fracture (PFF) compared to hips of a similar design but made of a different material.…
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(Reckitt Benckiser Healthcare (UK) Limited) Remaining stock should be quarantined and returned to original supplier for credit - class 2 action within 48 hours. (EL (14)A/04)
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The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the PRECICE Titanium subset of devices (Intra-Medullary Limb Lengthening (IMLL), Short, Unyte …
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List of Field Safety Notices from 5 to 9 August 2024.
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(Reckitt Benckiser Healthcare (UK) Limited) Remaining stock of batches should be quarantined and returned to original supplier for credit. - class 2 action within 48 hours. (EL (14)A/08)
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The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the modified MAGEC X system can now be used in the UK.
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…(Teva UK Limited) Precautionary batch recall of Evacal D3 1500mg/400iu Chewable Tablets after metal contamination was identified in a very small number of tablets…
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…Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that a potential product quality issue has been detected, relating to incomplete crimping of the metal crimp cap of OPDIVO 10mg/mL concentrate for solution for infusion (nivolumab) (1VLX10ML).…
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List of field safety notices (FSNs) from medical device manufacturers from 20 to 24 April 2015.
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List of Field Safety Notices from15 to 19 April 2024.
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Kyowa Kirin Limited is recalling specific batches as a precautionary measure, due to the reports of glass and cellulose fibre contamination, which was identified during stability and reference sample inspection.
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…This is due to the detection of metal particles in two infusion bags.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 August 2022.
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List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 September 2015.
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List of field safety notices (FSNs) from medical device manufacturers from 8 October to 12 October
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Summary List of field safety notices (FSNs) from medical device manufacturers from 22 - 26 August 2016
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(Various manufacturers) Leads to dislodgement of the tube with subsequent risk of airway loss. (MDA/2012/062)
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List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 March 2015.
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(All manufacturers and models) There is a risk of electric shock for clinicians or mortuary personnel while they remove implantable cardioverter defibrillators (ICDs). (MDA/2008/068)
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List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 January 2015.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 August 2017
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List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 June 2015.
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List of field safety notices (FSNs) from medical device manufacturers from 28 September to 2 October 2015.
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List of Field Safety Notices (FSNs) from 14 to 18 November 2022
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Summary List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 October 2017.
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List of field safety notices (FSNs) from medical device manufacturers from 19 to 23 October 2015.
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List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 September 2019.
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List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 June 2019
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Summary List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 June 2022
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List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 December 2015
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List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 November 2015
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Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 May 2022.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 April 2018.
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List of field safety notices (FSNs) from medical device manufacturers from 6 August to 10 August
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Summary List of field safety notices (FSNs) from medical device manufacturers from 6 - 10 June 2016
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Manufactured by NuVasive Specialized Orthopedics – supply of all MAGEC rods suspended to the UK market during a review by MHRA.
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Summary List of field safety notices (FSNs) from medical device manufacturers from 27 February - 3 March 2017