CORAIL AMT Neck Trials Surgical Instruments 의 안전성 경고

Safety alert

2018-05-29

2018-05-29

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180529.html

Medical device safety alert: depuy synthes corail amt neck trials surgical instruments medical device manufacturer, depuy synthes, has issued a medical device safety alert concerning its corail amt neck trials surgical instruments. the affected devices are identified as below: part description: a) corail amt neck seg 135d short; b) corail amt neck seg 135d kho; c) corail amt neck seg 135d std; d) corail amt neck seg 125d kla; e) corail amt neck seg 125d std part number: a) l94007; b) l94006; c) l94005; d) l94004; e) l94003 lot number: all lot the manufacturer addressed the potential for debris/material to be found behind the o-rings for some corail neck trials. according to the manufacturer, twelve complaints were received related to debris behind the o-ring. it has evaluated the issue and determined that none of these complaints have resulted in patient harm and found no increased risk to the patients. as a precautionary measure, the manufacturer determined that reworking the affected devices and removing the o-rings is the appropriate corrective action. the function of the device is unaffected by this change as the manufacturer currently markets products of the same design (i.E. without an o-ring). the affected users are advised to take the following actions: continue to follow the instructions for use in ifu-w90946 rev b regarding cleaning of these devices; medical facilities are to determine if any of the affected instruments are on hand, and contact their sales consultant to arrange for rework or replacement of these instruments; notify surgeons at their facility by providing them with a copy of the notice to ensure surgeons are aware of the field safety notice. according to the local supplier, the affected product part number: l94007, is distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 29 may 2018.