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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Midfoot Fusion Bolt

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  Class 2 Device Recall Synthes Midfoot Fusion Bolt see related information
Date Initiated by Firm March 08, 2013
Date Posted October 17, 2013
Recall Status1 Terminated 3 on August 12, 2015
Recall Number Z-0014-2014
Recall Event ID 65955
510(K)Number K081071  
Product Classification Screw, fixation, bone - Product Code HWC
Product Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Code Information Part Nos.: 04.111.210, 04.111.220, 04.111.230. with Lot Nos.; 2294209 through 7587547.
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Synthes Customer Service
610-719-5000
Manufacturer Reason
for Recall		 A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation.
FDA Determined
Cause 2		 Labeling design
Action An "Urgent Notice: Medical Device Recall" letter dated March 8, 2013 was sent to customers asking them to check their inventory, remove all affected product technical guides from use, and return them to Synthes along with the Verification form. Customer questions were directed to (610) 719-5450.
Quantity in Commerce 62
Distribution Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS.
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.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = SYNTHES (USA)
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