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 Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only Recalled by The Anspach Effort, Inc. Due to Recall was initiated due to the observation of...

Date: September 9, 2011
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 Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

Quantity: 1,805,022 cutting burs and 55,026 irrigation clips

Why Was This Recalled?

Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. As a result, it is possible to have a breach in the sterile barrier.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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