—#144437

Product

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

FDA product code: MOQ — Battery, Replacement, Rechargeable
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Dr, Palm Beach Gardens, Florida 33410-4235

Distribution

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

Timeline

Recall initiated: 2015-11-25
Terminated: 2018-11-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144437. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.