Stryker Orthopaedics 의 리콜

Recall

72498

Class 2

Z-0362-2016

2015-09-21

2015-12-02

Terminated

United States

2017-06-08

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141277

Stryker orthopaedics has received two customer complaints regarding duracon tibial wedge implants puncturing the packaging's tyvek lid(s).

On September 18, 2015, Stryker notified their Branches/Agencies of their action via email. The Branches/Agencies were instructed to quarantine affected devices. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated September 21, 2015 were sent to Branches/Agencies via UPS on 9/21/2015. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated September 21, 2015 were sent to Hospital Risk Managers via UPS on 9/23/2015. The notification instructed consignees on how to identify affected product; the related issue with the affected product; potential hazards; risk mitigations; and actions needed to be taken. Consignees were asked to contact their Stryker Orthopaedics Sales Representative to arrange for return of any recalled product. Customers were asked to complete and return the attached Product Recall Acknowledgement Form within 5 days and either email (strykerortho7984@stericycle.com or Fax (1-866-672-0627) the response form back. A point of contact was provided in case the customer had any questions 201.831.5826.