FDA Device

Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.

Hazard

Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON".

What You Should Do

Remedy

DePuy 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.

Products

Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
Brand
The Anspach Effort, Inc.
UPC
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

Units Affected

20 hand pieces