Z-1039-2008

Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached...

Name: Z-1039-2008 Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached...
Creator: The Anspach Effort, Inc.
Published: 2006-12-18
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2006-12-18 / Terminated / root cause: labeling and UDI

FDA source

The Anspach Effort, Inc. began a recall of Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm... on 2006-12-18. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1039-2008
Status: Terminated
Initiated: 2006-12-18
Posted: 2008-02-13
Terminated: 2012-07-06
Recalling firm: The Anspach Effort, Inc.
Product: Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.
Product code: ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 7,399 total units
Distribution: Worldwide Distribution
Product codes and lots: All Serial Numbers.

Product code ERL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)