Recall Z-1994-2016
The Anspach Effort, Inc. · initiated January 15, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Universal Battery Charger II (UBC II)
Codes / lots: Part # 05.001.204 Serial #'s 10615 thru 12616
Reason for recall
The device is reported to enter safe mode and is no longer able to charge batteries.
FDA-determined cause: Process design
Action taken
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.
Details
- Recall number
- Z-1994-2016
- Initiated
- January 15, 2016
- Terminated
- December 14, 2016
- Product code
- MOQ – Battery, Replacement, Rechargeable
- 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
- Recalling firm
- The Anspach Effort, Inc., Palm Beach Gardens, FL