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Terminated

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

FDA Recall Z-2126-2016 · Posted None

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeMOQ
Date Initiated2015-11-25
Date Terminated2018-11-14
Product Quantity20 hand pieces

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".

Firm 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 Consultant. For further questions regarding this, please call (561) 627-1080.

Root Cause

Labeling design

Distribution Pattern

US Distribution to the state of : VA and Internationally to: Thailand and UK

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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