Class II — Potential Health Hazard

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

Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397 Recalled by Greatbatch Medical Due to Greatbatch Medical has voluntarily initiated a Recall for...

Date: April 23, 2017
Company: Greatbatch Medical
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 Greatbatch Medical directly.

Affected Products

Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).

Quantity: 205

Why Was This Recalled?

Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp Handle) and EZ Clean" Linear Broach Handle. Greatbatch Medical has received reports that that the product is breaking at the welds and that the locating pin at the distal end of the instrument is breaking off during use.

Where Was This Sold?

This product was distributed to 1 state: TX

Affected (1 state)Not affected

About Greatbatch Medical

Greatbatch Medical has 16 total recalls tracked by RecallDetector.

Related Recalls

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