Recall Z-1994-2016 ยท MOQ Battery, Replacement, Rechargeable
The Anspach Effort, Inc.
Universal Battery Charger II (UBC II)
| Date | Jan 15, 2016 |
| Status | Terminated |
| Reason | The device is reported to enter safe mode and is no longer able to charge batteries. |
| Root cause | Process design |
| 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. |
| Quantity | 1,992 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.