Greatbatch Medical: Medical Device Recall in 2017 - (Recall #: Z-2055-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: April 23, 2017

Date Posted: May 17, 2017

Recall Number: Z-2055-2017

Event ID: 77120

Reason for Recall:

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.

Status: Terminated

Product Quantity: 205

Code Information:

Lot numbers : Linear Straight Broach Handle (Rasp Handle): 2988946, 3138186, 3185601, 3287315, 3300879, 3333172, 3433392, 3332697. EZ Clean" Linear Broach Handle: 3508491.

Distribution Pattern:

US Distribution to the state of : TX

Voluntary or Mandated:

Voluntary: Firm initiated