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U.S. Department of Health and Human Services

Class 2 Device Recall The Synthes Hohmann Retractor

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  Class 2 Device Recall The Synthes Hohmann Retractor see related information
Date Initiated by Firm February 11, 2014
Date Posted April 15, 2014
Recall Status1 Terminated 3 on September 10, 2015
Recall Number Z-1457-2014
Recall Event ID 67560
Product Classification Retractor - Product Code GAD
Product The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm

Product Usage: Used to expose bone for procedures.
Code Information part no. 399.24, lot number T974302
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 The Synthes Hohmann Retractor was mis-etched on the product and package as part number 399.24 instead of part number 399.22.
FDA Determined
Cause 2		 Error in labeling
Action Synthes sent an Urgent Notice: Medical Device Recall letter dated February 11, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to Complete the attached Verification Section form. For questions call 610-719-5450.
Quantity in Commerce 20
Distribution Worldwide Distribution - USA Nationwide Distribution in the states of: TN, MD, NY, IN, NJ, WA, VA,and the country of Canada.
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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