Device Recall Integra 의 리콜

Recall

76693

Class 2

Z-1539-2017

2017-03-03

Terminated

United States

2018-05-21

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153928

Voluntary recall/removal of panta and panta xi nails because there may be the potential that the internal and external package seal does not provide the level of sterility intended.

Integra sent "Urgent Medical Device Recall Letters and Return Response Forms" dated March 3, 2017 to their distributors and customers. All customers were asked to examine their inventory to determine if they had the recalled lots and if they did they are instructed to stop using them immediately. Distributors are asked if the recalled product was further distributed, those customers should be notified and instructed to follow the recalling procedures. The return response form should be completed, even if they do not have any recalled lots, annotating the amount of product and list a record of the lot numbers. The return response form should be sent back to Integra via email to: FCA2@integralife.com or via fax to: 1-609-750-4220. Upon receipt by Integra, if your company has identified recalled lots, Customer Service will contact the customer and provide an RMA number and directions to return the product, as well as input an order to replace the quantity indicated on the return response form. Should any customer have any questions regarding the recall instructions, they can contact Customer Service at 1-800-654-2873. To return units under field inventory, customer can contact 1-888-601-0203, option 2. For further questions, please call (717) 309-3966.