Recall Z-2837-2016 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
The Anspach Effort, Inc.
G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
| Date | Aug 26, 2016 |
| Status | Terminated |
| Reason | Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were distributed. |
| 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 | 177 |
| 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 |