Recall Z-1041-2008 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
The Anspach Effort, Inc.
Anspach Xmax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.
| Date | Feb 13, 2008 (initiated Dec 18, 2006) |
| Status | Terminated |
| Reason | Incorrect Sterilization Process --The Operating Manual for the product contains an incorrect statement regarding the sterilization of the Autolube foot control. The manual states that the product can withstand ETO sterilization, but there is no data to support this process. |
| Root cause | Labeling False and Misleading |
| Action | Anspach issued an Urgent Device Correction letter on 11/27/06, to all manual holders advising them of the error and requested that they update the manual with the corrected instructions. A reply receipt confirming notification was included. |
| Quantity | 7,399 total units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.