Anspach BlackMax Pneumatic Motor System recallZ-1039-2008 · The Anspach Effort, Inc. · initiated Dec 18, 2006
Terminated All recalls posted in February 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from The Anspach Effort, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling False and Misleading
What the company is doing
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.
Recall details
- Recall number
- Z-1039-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 18, 2006
- Posted by the FDA
- Feb 13, 2008
- Recalling firm
- The Anspach Effort, Inc.
- Quantity
- 7,399 total units
- Product code
- ERL
- FDA submissions
- K831756, K965080
- Distribution
- Worldwide Distribution
Product description
Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.
Code information (models, lots, serial numbers)
All Serial Numbers.
Other devices under the same FDA submission
2 devices cleared under K831756, K965080 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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