Device Recall Dekompressor Percutaneous Discectomy Probe 의 리콜

Recall

66456

Class 2

Z-0127-2014

2013-11-04

2013-11-01

Terminated

United States

2014-04-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122425

Stryker has identified a potential for the auger and/or cannula to fracture when the dekompressor is used contrary to the warnings in the instructions for use (ifu). specifically, manually bending the cannula can weaken the device and may result in a fracture of the auger and/or cannula. this could result in the need for additional medical intervention to remove the broken piece, pain or loss of m.

On 11/4/13, an URGENT MEDICAL DEVICE Recall Notification was sent to all domestic consignees via mail and foreign by email. An advisory was sent to every physician that uses any of the products listed. Every physician that uses any of these products must print their name and sign below which means you acknowledge that youve received a copy of the attached advisory and that you understand the information regarding the proper usage of the Decompressor. Once the form has been signed by all physicians, the form must be completed and signed by the recall coordinator. Please fax to 866-521-2762 or email to kara.spath@stryker.com.