Anspach MicroMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; B
FDA device recall Z-1040-2008 · posted 2008-02-13 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- ERL
- Quantity affected
- 7,399 total units
- Distribution
- Worldwide Distribution
- Date initiated
- 2006-12-18
- Date posted
- 2008-02-13
- Date terminated
- 2012-07-06
- Location
- Palm Beach Gardens, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.