Recalls / —

—#144629

Product

Universal Battery Charger II (UBC II)

FDA product code

MOQ — Battery, Replacement, Rechargeable

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Part # 05.001.204 Serial #'s 10615 thru 12616

Why it was recalled

The device is reported to enter safe mode and is no longer able to charge batteries.

Root cause (FDA determination)

Process design

Action the firm took

DePuy Synthes sent an "Urgent Notice- Medical Device Recall (Removal) letter dated January 15, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informing them of the recall (removal) and asking them to return the UBC II when it display the blue flashing lights that indicate service and to contact DePuy Synthes Customer Support at 800-327-6887 option 2 for return device and arrange to repair or replacement. Any other question please contact the Complaint Handling Unit Manager at 561-494-3673.

Recalling firm

Firm

The Anspach Effort, Inc.

Address

4500 Riverside Dr, Palm Beach Gardens, Florida 33410-4235

Distribution

Distribution pattern

USA Distribution to the states of : AR, AZ, CA, CO, FL, IL, IN, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OK, OR, PA, SC, TN, TX, VA, WA, WI and Hawaii

Timeline

Recall initiated

2016-01-15

Terminated

2016-12-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #144629. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.