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Terminated

Anspach Xmax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.

FDA Recall Z-1041-2008 · Posted 2008-02-13

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeERL
Date Initiated2006-12-18
Date Terminated2012-07-06
Product Quantity7,399 total units

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.

Firm 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.

Root Cause

Labeling False and Misleading

Distribution Pattern

Worldwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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