Device Recall SwishTapered Implant 의 리콜

Recall

76111

Class 2

Z-1112-2017

2016-12-12

2017-01-28

Terminated

United States

2017-05-22

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152174

The extender product code (9037-03) that is packaged with the swishtapered (part number 933308; lot number 73241) implant was packaged in the incorrect position. this discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.

Customer notification letters were sent on 12/12/16. Customers were requested to review inventory for the affected product. Complete and return the Acknowledgement and Recall Return Form within 48 hours. If customers are an authorized distributor the firm requests that they identify those customers that may have been shipped the affected product lot and contact those customers to inform them of the issue within 48 hours of receipt of the notification in order to provide the customers with replacement product. If customers have any of the affected product the firm will send a replacement part. Any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.