Recall Z-2839-2016 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
The Anspach Effort, Inc.
G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
| Date | Aug 26, 2016 |
| Status | Terminated |
| Reason | The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503. |
| Root cause | Device Design |
| Action | On April 26, 2016 DePuy Synthes sent a letter informing their customers of the recall. ACTION REQUIRED Our records show that your facility has received one or more of product(s) subject to the recall (correction). The Anspach Effort, Inc. asks that you: 1) There is no requirement for retaining your inventory of Gl Dissection Tools. 2) To ensure Gl Cutting Tool & Attachment compatibility, please reference Table 1 to review which Attachments are compatible. The Cutting TooVAttachment combination noted with a check mark in Table I will function as intended. The Cutting Tool/Attachment combinati |
| Quantity | 63 |
| Distribution | AZ, DC, CA, MD, MI, and OR Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113476 | ANSPACH DISSECTION TOOLS The Anspach Effort, Inc., Dec 16, 2011 |