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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Soft Tissue Retractor Small Extendible

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 Class 2 Device Recall Synthes Soft Tissue Retractor Small Extendiblesee related information
Date Initiated by FirmAugust 01, 2013
Date PostedNovember 29, 2013
Recall Status1 Terminated 3 on April 16, 2015
Recall NumberZ-0429-2014
Recall Event ID 66530
Product Classification Retractor - Product Code GAD
ProductSynthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Code Information Part J5957AC (old), and Part J5957F (new)
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information ContactCustomer Support
610-719-5000
Manufacturer Reason
for Recall		The small extendible Soft Tissue Retractor was recalled due to locking nut (clamping sleeve) malfunction.
FDA Determined
Cause 2		Use error
ActionSynthes 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.
Quantity in Commerce374
DistributionWorldwide Distribution - USA (nationwide) and Internationally to Canada and Mexico.
Total Product Life CycleTPLC 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.
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