Device Recall Straumann Emdogain 의 리콜

Recall

79738

Class 2

Z-1695-2018

2018-03-23

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163229

A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.

Customer notification letters were distributed 3/23/18. Action to be taken: 1. Check your inventory for the above listed article and lot numbers and return all unused/unpackaged Emdogain using the enclosed prepaid UPS label as indicated on the Customer Confirmation Form. Your account will be credited upon receipt. 2. If you have already unpacked the Emdogain from the outer box, the lot number on the blister package will be different. Please check your Emdogain for the syringe blister lot numbers listed above and return them for credit using the enclosed prepaid UPS label as indicated on the Customer Confirmation Form. 3. If you have already used the Emdogain with the above listed article and lot numbers, please document receipt of this Field Safety Notice in the applicable patient files. Complete and return the enclosed Customer Confirmation Form via fax to the number listed on the form. Please also report the outcome of the surgical treatment with this product on the enclosed Customer Treatment Outcome Form and fax the form to the number listed on the form. 4. For all cases complete and return the enclosed Customer Confirmation Form and return to Straumann using the enclosed UPS label (if returning product) or via fax (if notifying us the product has already been used). This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. Updated Notification letters including an additional lot number were distributed beginning 4/18/18.