Synthes Soft Tissue Retractor Small Extendible 의 리콜

Recall

66530

Class 2

Z-0429-2014

2013-08-01

2013-11-29

Terminated

United States

2015-04-16

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122553

The small extendible soft tissue retractor was recalled due to locking nut (clamping sleeve) malfunction.

Synthes sent an Field Safety Notification letter dated August 1, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to take the following actions: Exchange the old surgical technique guide with the new guide version F provided with this notification. Review the revised surgical technique guide. Forward this Field Safety Notification to anyone in your facility that needs to be informed. If the technique guide has been forwarded to another facility, contact that facility. Maintain awareness of this notice until all technique guides have been exchanged. Maintain a copy of this notice. Please complete and return this page by either of the following methods: Fax: 877-567-9320 or Scan/email: FieldAction@synthes.com Thank you for your attention to this issue.