|Date Initiated by Firm
||August 01, 2013
|Date Posting Updated
||November 29, 2013
||Terminated 3 on April 16, 2015
|Recall Event ID
||Retractor - Product Code GAD
||Synthes Soft Tissue Retractor Small Extendible.
Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
||Part J5957AC (old), and Part J5957F (new)
| Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
|For Additional Information Contact
|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
Thank you for your attention to this issue.
|Quantity in Commerce
||Worldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico.
|Total Product Life Cycle
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.