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
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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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