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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Sterile Guide Rods

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  Class 2 Device Recall Synthes Sterile Guide Rods see related information
Date Initiated by Firm October 03, 2016
Date Posted November 19, 2016
Recall Status1 Terminated 3 on July 06, 2017
Recall Number Z-0640-2017
Recall Event ID 75502
Product Classification Reamer - Product Code HTO
Product 3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
Code Information Catalog ID 355.041S, Lot Numbers: H085635; H087271; H094462; H111419; H136756
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact
610-719-6500
Manufacturer Reason
for Recall		 The peel pouches for the affected reaming rods and extraction hooks are delaminating.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action DePuy Synthes mailed a Customer Safety Advisory Notice on October 19, 2016 to affected customers advising them of the malfunction, potential risks and the actions needed to be taken to avoid injury, as they work on a solution to correct the problem.
Quantity in Commerce 319 units
Distribution Distributed Nationwide
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.
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