Recall Z-2126-2016 ยท MOQ Battery, Replacement, Rechargeable
The Anspach Effort, Inc.
Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
| Date | Nov 25, 2015 |
| Status | Terminated |
| Reason | Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON". |
| Root cause | Labeling design |
| Action | 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 Con |
| Quantity | 20 hand pieces |
| Distribution | US Distribution to the state of : VA and Internationally to: Thailand and UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.