Urgent Field Safety Notice FSCA260 : BIPOLAR CUP TRIAL HEAD - Update reprocessing of the Bipolar Cup trial head

 

 

Affected Medical Device : Bipolar Cup Trial Head

 

MDA Reference Number : MDA/FCA/2021-P144

 

MDA Registration Number : GC86706621718

 

Decription : The Bipolar Cup trial heads consist of the indivisual components bipolar trial head and locking ring. During the re-evaluation of the sterilization process, it was determined that the mechanical pre-cleaning and cleaning /disinfection in the disassmbled state, as well as the information on sterilization in the non-assembled state, are not sufficiently described in the instructions for use.

 

Local Establishment Contact Detail :

Winnie Hii Lin Lin
Senior Executive, Regulatory Affairs
Tel: 03 - 78414200
Crown Penthouse,Plaza IBM,8, First Avenue,Persiaran Bandar Utama,47800 Petaling Jaya,Selangor,Malaysia.
http://www.bbraun.com

Email : winnie.hii@bbraun.com

 A copy of FSN.