Bending/Cutting Pliers with Nose, for LOCK Plates 2.0 의 리콜

Recall

RC-2014-RN-01359-1

Class II

2014-12-23

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01359-1

The pliers have the potential for tip breakage while bending the extra-large compact 2.0 mandible locking plates (part numbers 447.412, 447.420, 447.422, 447.423, 447.424, 447.425, 447.426, 447.412s, 447.420s, 447.422s, 447.423s 447.424 s, 447.425 s and 447.426s ) with the last hole feature of the instrument.If a nonconforming bending/cutting pliers with nose for lock plates 2.0 is used and breaks while in the operating room, surgical delay may occur while alternate bending or cutting instruments are located.To date, there have been no reports of adverse events related to this issue. such reports are unlikely to occur as the bending/cutting pliers with nose for lock plates 2.0 are not used in direct contact with the patient but rather on the plates before they are inserted.

Customers are requested to:- 1. Check inventory immediately for the affected units; 2. Synthes will contact customers to arrange a replacement or credit as available; 3. An interim inspection procedure had been provided to customers whilst awaiting replacement stock. This action has been closed-out on 14/07/2016.