Recall Z-2126-2016
The Anspach Effort, Inc. · initiated November 25, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
Codes / lots: 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
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: Labeling design
Action taken
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.
Details
- Recall number
- Z-2126-2016
- Initiated
- November 25, 2015
- Terminated
- November 14, 2018
- Product code
- MOQ – Battery, Replacement, Rechargeable
- Quantity
- 20 hand pieces
- Distribution
- US Distribution to the state of : VA and Internationally to: Thailand and UK
- Recalling firm
- The Anspach Effort, Inc., Palm Beach Gardens, FL