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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes Small Electrict Drive

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 Class 2 Device Recall Synthes Small Electrict Drivesee related information
Date Initiated by FirmNovember 14, 2014
Date PostedFebruary 25, 2016
Recall Status1 Open3, Classified
Recall NumberZ-1017-2016
Recall Event ID 69974
Product Classification Pliers, surgical - Product Code HTC
ProductSynthes Small Electric Drive (SED)
Code Information All lots from production launch
FEI Number 1045834
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Dr
Palm Beach Gardens FL 33410-4235
For Additional Information ContactComplaint Handling Unit
561-494-3673
Manufacturer Reason
for Recall		May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start.
FDA Determined
Cause 2		Other
ActionOn November 13, 2014 DePuySynthes sent a letter to all their consignees informing them of the recall and asked them to return the product. A letter and a response letter were sent to all customers that received the device. For contact - The Complaint Handling Unit Manager at 561-494-3673 or the customer DePuy Synthes Sales Consultant.
Quantity in Commerce302 (23 in the USA and 279 OUS)
DistributionCO, FL, LA, ID, CA, KS, IL, TX, VA, MI, NC, WA, AR, NY, NC, AZ, and Hawaii Canada, Hong Kong, Chile, Israel, Poland, Turkey, Itly, Malaysia, Ireland, Korea, Germany, Spain, Norway, Sweeden, England, Fiji, Switzerland, Belgium, Austria, Netherlands, France, Japan, China, India, Thailand, Russia, Zaire, Taiwan, and Australia.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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