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Terminated

Universal Battery Charger II (UBC II)

FDA Recall Z-1994-2016 · Posted None

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeMOQ
Date Initiated2016-01-15
Date Terminated2016-12-14
Product Quantity1,992

Reason for Recall

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

Firm Action

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.

Root Cause

Process design

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

Official Source

View FDA Recall →

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

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