RECALL: MEDICAL DEVICE RECALL LISTING JANUARY 2022

The list below contains Medical Device Recall for the month of January 2022. This list provides recall reporting information to MDA by establishment in accordance to requirement stipulated in Section 42, Act 737 and Regulation 7 and 8 of Medical Device (Duties and Obligations of Establishment) Regulations 2019.

Recall is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices in the Malaysia market. Recall is any action taken by the establishment of the medical device to remove the medical device from the market or to retrieve the medical device from any person to whom it has been supplied and to notify its affected person of its defectiveness or potential defectiveness.

If you have experienced any safety and performance issue with one of the medical devices listed for Recall action, please seek advice from your healthcare professional as soon as possible.

MEDICAL DEVICE RECALL LISTING JANUARY 2022

Date Received	Ref. No.	Recall Type	Product Name	Product Registration	Recall Class	Reason of Recall	Recalling Establishment	Establishment License
10/1/2022	MDA/PMSV/R2022-001	Voluntary Recall	1688 4K Camera Control Unit with Advanced Imaging Modality	GA1026461936035	Class III	A21 Labelling, Instructions for Use or Training Problem	Stryker Corporation (Malaysia) Sdn Bhd	MDA-542-WDP44515
11/1/2021	MDA/PMSV/R2022-002	Voluntary Recall	NobelReplace CC RP 4.3x11.5 mm	GC95763250017	Class II	A05 Mechanical Problem	Kavo Kerr Group Malaysia Sdn. Bhd.	MDA-818-D69815
11/1/2021	MDA/PMSV/R2022-003	Voluntary Recall	AGILON® Glenoid Cementless	GC938121294519	Class III	A02 Manufacturing, Packaging or Shipping Problem	ENRICH MEDSURG SDN BHD	MDA-1520-W120
19/1/2021	MDA/PMSV/R2022-004	Voluntary Recall	Biolox® delta Ceramic V40™ Femoral Head 32/ -4.0mm (6570-0-032) Biolox® delta Ceramic V40™ Femoral Head 36/ +0.0mm (6570-0-136) Biolox® delta Ceramic V40™ Femoral Head 32/ +4.0mm (6570-0-232)	GD83312836918 GC48361787918 GC23592916318	Class III	A21 Labelling, Instructions for Use or Training Problem	Stryker Corporation (Malaysia) Sdn Bhd	MDA-542-WDP44515
25/1/2021	MDA/PMSV/R2022-005	Voluntary Recall	ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM	GC18985179017	Class III	A25 No Apparent Adverse Event	Boston Scientific (M) Sdn Bhd	MDA-138-WDP5315
28/1/2021	MDA/PMSV/R2022-006	Voluntary Recall	C315HIS Delivery Catheter	GD98537902218	Class II	A05 Mechanical Problem	Medtronic Malaysia Sdn Bhd	MDA-0074-WDP7414
4/1/2021	MDA/PMSV/R2022-007	Voluntary Recall	CrAg® LFA	IVDC46685141018	Class II	A09 Output Problem	All Eights (M) Sdn Bhd	MDA-0037-WDP3714

* The information contained in the Medical Device Authority Recall database is released under Regulation 7(8) and Regulation 8 (5) of Malaysia’s Medical Device Regulations 2019.

Post Market Surveillance & Vigilance Unit

Medical Device Authority,
Ministry of Health Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya,

Selangor, MALAYSIA.

Off. No: +603-8230 0300
Fax. No: +603-8230 0200