Field Safety Notice - 29 may to 2 June 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 29 May to 2 June 2017
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
Beckman Coulter: Synchron AQUA CAL Level 1
31 May 2017
IVDs, clinical chemistry
MHRA reference: 2017/006/001/601/002
Exactech: Logic Fit Tibial Tamp Head Instrument
23 May 2017
Orthopaedic surgical instruments - Insertion/extraction tools
MHRA reference: 2017/005/026/701/003
Exactech: Equinoxe Modular and Non-Modular Pilot Tip Reamers
23 May 2017 - 05232017-03
Orthopaedic surgical instruments - Insertion/extraction tools
MHRA reference: 2017/005/026/701/005
Exactech: Novation Calcar Planer Guide Tip
23 May 2017 - 05232017-02
Orthopaedic surgical instruments - Insertion/extraction tools
MHRA reference: 2017/005/026/701/004
Magellan: LeadCare/ LeadcareII/Leadcare Ultra/Leadcare Plus
24 May 2017
IVDs, clinical chemistry
Model: LeadCare/ LeadcareII/Leadcare Ultra/Leadcare Plus
MHRA reference: 2017/006/001/291/012
Roth: MOBELI Stabi Vario / MOBELI Dual Grip
01 June 2017
X-ray, general
Model: MOBELI Stabi Vario / MOBELI Dual Grip
MHRA reference: 2017/006/001/291/005
Sentinel: Creatinine (Enzymatic)
22 May 2017
IVDs, clinical chemistry
MHRA reference: 2017/006/001/291/011
TransMedics: OCS Heart
01 June 2017
Storage and collection devices
Model: 1200
MHRA reference: 2017/005/026/601/004
Zimmer: Werber Countersink Cannulated for micro CBS screw
23 May 2017
Osteosynthesis, bone screws
MHRA reference: 2017/005/031/701/012