Recall Z-2253-2016 ยท HBC Motor, Drill, Electric
The Anspach Effort, Inc.
Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.
| Date | Jun 15, 2016 |
| Status | Terminated |
| Reason | The graphics at the attachment interface indicating locked and unlocked position are reversed. |
| Root cause | Employee error |
| Action | The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE-RECALL (Removal)" letter dated June 15, 2016 to its customers. The letter described the product, problem and actions to taken. The customers were instructed to review your inventory and immediately remove the product subject to this recall from stock; If you DO HAVE any of the identified devices, please take the following steps: " Ensure anyone in your facility impacted by this notification reads this letter carefully. Customer Letter Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicat |
| Quantity | 18 |
| Distribution | Worldwide Distribution: US Distribution to states of: GA and FL; and country of: Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133604 | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS The Anspach Effort, Inc., Jan 10, 2014 |