Legacy(TM) 3 Implant 의 리콜

Recall

78350

Class 2

Z-0185-2018

2017-10-10

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159290

One reported complaint and discovered that the outer vial was out of round and undersized. therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. as a result, the cap could possibly not be screwed on properly and the sterilization compromised.

The firm, Implant Direct Sybron Manufacturing, LLC, sent an "URGENT: Safety Alert/Advisory Notice" letter to its distributors/customers on 10/10/2017. Distributors were instructed as follows: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form within 48 hours. 3. If you are an authorized Implant Direct Sybron Manufacturing distributor, we request that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of this notification in order to provide the customers with replacement product." Enclosed within this notification, you will find a padded return envelope with replacement product. Please return affected product in the padded envelope. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425. Customers were instructed as follows: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form within 48 hours. Please share this information with your staff and retain this notification as part of your documentation. Enclosed within this notification, you will find a padded return envelope with replacement product. Please return affected product in the padded envelope. If you have any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425."