Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity fo

FDA device recall Z-0429-2014 · posted 2013-11-29 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.

Action taken

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.

Root cause

Use error

Status

Terminated

Product code

GAD

Quantity affected

374

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico.

Date initiated

2013-08-01

Date posted

2013-11-29

Date terminated

2015-04-16

Location

West Chester, PA