Device Recall Implant Direct, INTERACTIVE HEALING COLLAR 의 리콜

Recall

78917

Class 2

Z-0539-2018

2018-01-23

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160855

Interactive healing collar, lot number 104203, labeled as sterile with distributed prior to being sterilized.

The firm initiated their recall on 01/23/2018 by letter. the recall notices requested the following actions by the distributors: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form with the affected product, if available, 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." The letter disseminated to the physician requested the following actions: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form with the affected product, if available, within 48 hours."