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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes small Electric Drive (SED)

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  Class 2 Device Recall Synthes small Electric Drive (SED) see related information
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
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
For Additional Information Contact Complaint Handling Unit Manager
561-494-3673
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.
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
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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