Field Safety Notice: 12 to 16 October
List of field safety notices (FSNs) from medical device manufacturers from 12 to 16 October 2020.
Overview
If you receive a field safety notice (FSN) from a manufacturer you must always act on it.
MHRA publishes the following for information only.
If you have a question about a particular FSN contact the manufacturer.
Latest FSNs
View the latest FSNs
View a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Aesculap - B Braun: EN NOVATE MIS REMOVAL KEY SHORT
30 September 2020
Orthopaedic surgical instruments - insertion/extraction tools
Model: SZ380R
MHRA reference: 2020/010/006/487/009
Biomet (Zimmer): Surgical devices, non-powered
13 October 2020
Surgical devices, non-powered
MHRA reference: 2020/010/014/291/001
B Braun: Redyrob® Transplus Closed Wounddr. System
05 October 2020
Wound drains
Model: 5526604
MHRA reference: 2020/010/007/601/008
CAIRE: Companion 1000® Liquid Oxygen Portable
16 July 2020
Therapy, oxygen & fitments
MHRA reference: 2020/009/010/701/023
Cantel: Innova E-Series Endoscope Reprocessor
14 October 2020
Cssd wash/clean/drying equipment
MHRA reference: 2020/010/015/291/006
Draeger: Infinity Acute Care System (M540)
October 2020
Monitors, patient
MHRA reference: 2020/010/015/291/002
Exactech: Equinoxe Platform Fracture Stem, 6.5mm
08 October 2020
Joint prosthesis, shoulder
MHRA reference: 2020/010/013/701/026
Exactech: Equinoxe Cage Glenoid, Posterior Augment, Medium
06 October 2020
Joint prosthesis, shoulder
MHRA reference: 2020/010/009/701/020
Geistlich Pharma: Geistlich Bio-Oss Pen
12 October 2020
Implants, dental
MHRA reference: 2020/010/009/487/016
HAAG-STREIT SURGICAL: Floor Stand FS 2-11 / FS 2-15 in combination with HS Hi-R NEO 900 / HS
Hi-R NEO 900A
01 October 2020
Surgical equipment, miscellaneous
Model: FS 2-11 / FS 2-15
MHRA reference: 2020/010/008/487/007
Luminex: VERIGENE Assay Products
14 October 2020
IVDs, bacteriology
MHRA reference: 2020/010/015/291/001
Medtronic: InterStim Percutaneous Extension
October 2020
Implants, active, leads, neuro
Model: 3560022, 3560030
MHRA reference: 2020/010/015/291/003
MicroPort Orthopedics: PROFEMUR(R) Ti Long/X-long Modular Necks
10 July 2020
Joint prosthesis, hip
MHRA reference: 2020/010/014/291/005
Novocure: Optune
07 October 2020
Therapy, electrotherapy
Model: TFH9100
MHRA reference: 2020/010/008/487/005
Renishaw Mayfield: neuro|mate stereotactic system
12 October 2020
Surgical navigation system and accessories
MHRA reference: 2020/010/012/601/003
Signus Medizintechnik: RABEA PEEK
09 October 2020
Spinal implants
Model: Cervical Cage angled 4x12x14mm 5°
MHRA reference: 2020/010/012/487/023
Steripack: Syringe 10 ml with 0,9% sodium chloride
09 October 2020
Vascular cannula/catheter accessories
MHRA reference: 2020/010/012/487/018
TORNIER: Inspyre™ Implant
23 September 2020
Joint prosthesis, shoulder
Model: Interpositional Shoulder Implant
MHRA reference: 2020/010/002/601/004