Device Recall G1 High Speed Electric Handpiece Air Cooled (eG1A) 의 리콜

Recall

74447

Class 2

Z-2253-2016

2016-06-15

Terminated

United States

2016-12-14

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147607

The graphics at the attachment interface indicating locked and unlocked position are reversed.

The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE-RECALL (Removal)" letter dated June 15, 2016 to its customers. The letter described the product, problem and actions to taken. The customers were instructed to review your inventory and immediately remove the product subject to this recall from stock; If you DO HAVE any of the identified devices, please take the following steps: " Ensure anyone in your facility impacted by this notification reads this letter carefully. Customer Letter Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating product subject to the recall has been located. Indicate the number of devices found. " The RMA information has been filled in for your convenience. " Please include your name, title, address, telephone number, signature and date in the spaces provided. " Send a copy of the completed Verification Section to DePuy Synthes, Customer Quality Department by: " Fax: (561) 627-2682 " Scan/email: DPYUS-PowerToolsFieldActions@its.jnj.com " Giving it to your DePuy Synthes Sales Consultant. " This return documentation acknowledges your receipt of medical device removal information. " Return the affected product to your DePuy Synthes Sales Consultant " Keep this notice visibly posted for awareness until all products subject to this recall has been returned. While processing your returns, please maintain a copy of this notice with the product subject to this action and keep a copy for your records. If you DO NOT HAVE the identified product, please take the following steps: " Complete the attached Verification Section (page 3 of this letter) by checking the appropriate box indicating that no affected product has been located. Include your name, title, address, telephone number, signature and date in the spaces provided. " Send a copy of the completed Verification Section to DePuy Synthes, Customer Quality Department by Fax: (561) 627-2682 " Scan/email: DPYUS-PowerToolsFiel