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U.S. Department of Health and Human Services

Class 2 Device Recall Battery Oscillator II

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 Class 2 Device Recall Battery Oscillator IIsee related information
Date Initiated by FirmNovember 25, 2015
Create DateJuly 05, 2016
Recall Status1 Terminated 3 on November 14, 2018
Recall NumberZ-2126-2016
Recall Event ID 73198
Product Classification Battery, replacement, rechargeable - Product Code MOQ
ProductBattery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
Code Information Part Number 530.710, Serial Numbers 101066, 101067, 101068, 101069, 101070, 101071, 101072, 101073, 101074, 101075, 101076, 101077, 101078, 101079, 1011080, 101081, 101082, 101083, 101084, 101085  
FEI Number 1045834
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Dr
Palm Beach Gardens FL 33410-4235
For Additional Information ContactJennifer Breston
561-627-1080
Manufacturer Reason
for Recall		Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON".
FDA Determined
Cause 2		Labeling design
ActionDePuy Synthes sent an Urgent Notice Recall Notification dated November 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to review their inventory and immediately remove any affected devices, complete the verification section of the letter and return it to the Anspach Effort Inc., and return any affected product to their DePuy Synthes Sales Consultant. Any questions regarding this recall / removal contact the Complain Handling Unit Manager at (561) 494-3673 or their DePuy Synthes Sales Consultant. For further questions regarding this, please call (561) 627-1080.
Quantity in Commerce20 hand pieces
DistributionUS Distribution to the state of : VA and Internationally to: Thailand and UK
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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