Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Anspach Pneumatic and Electric Motor Systems. Intended for cutting and Recalled by The Anspach Effort, Inc. Due to Several attachments and handpieces failed to meet the...

Date: May 8, 2014
Company: The Anspach Effort, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact The Anspach Effort, Inc. directly.

Affected Products

Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.

Quantity: 115,988 units

Why Was This Recalled?

Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device.

Where Was This Sold?

This product was distributed to 49 states: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC

Affected (49 states)Not affected

About The Anspach Effort, Inc.

The Anspach Effort, Inc. has 261 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report