Recall Z-1907-2014 ยท HBB Motor, Drill, Pneumatic
The Anspach Effort, Inc.
ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems
| Date | Jun 25, 2014 (initiated Nov 28, 2012) |
| Status | Terminated |
| Reason | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. |
| Root cause | Process design |
| Action | The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887. For questions regarding this recall call 561-494-3706. |
| Quantity | 130 |
| Distribution | Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040186 | ANSPACH MRI SAFE SURGICAL DRILL SYSTEM The Anspach Effort, Inc., Apr 15, 2004 |