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Class 2 Device Recall Synthes small Electric Drive (SED) |
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Date Initiated by Firm |
August 14, 2014 |
Date Posted |
February 03, 2016 |
Recall Status1 |
Terminated 3 on February 05, 2016 |
Recall Number |
Z-0747-2016 |
Recall Event ID |
73000 |
Product Classification |
Pliers, surgical - Product Code HTC
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Product |
Synthes Small Electric Drive (SED). For use in general traumatology. |
Code Information |
All Lots |
Recalling Firm/ Manufacturer |
The Anspach Effort, Inc. 4500 Riverside Dr Palm Beach Gardens FL 33410-4235
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For Additional Information Contact |
Complaint Handling Unit Manager 561-494-3673
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Manufacturer Reason for Recall |
The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
On 11/13/2014 DePuy Synthes send a letter to all their customers informing them of the recall of all the lots of the Small Electric Drive (SED) with instructions to returned and possible exchange. Contact is Complaint Handling Unit Manager at 561-494-3673 |
Quantity in Commerce |
599 each |
Distribution |
Worldwide Distribution-US (nationwide) including the states of AR, AZ, CA, CO, FL, ID, IL, KS, LA, MI, NC, NY, TX, WA, VA and HI, and the countries of Germany, Hong Kong, Chile, Israel, Poland, Italy, Turkey, Italy, Singapore, Ireland, Korea, Spain, Norway, Denmark, Great Britain, Finland, Belgium, Netherlands, France, Japan, Sweden, Switzerland, Austria, China, India, Thailand, Russia, New Zealand, Zaire, Australia, Taiwan, and Malaysia. |
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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