Home / Recalls / Greatbatch Medical / Z-2055-2017

Z-2055-2017 Class II Terminated

Recalled by Greatbatch Medical — Plymouth, MN

FDA device recall Z-2055-2017 was initiated by Greatbatch Medical on April 23, 2017 and is designated Class II. 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 prod… The recall status is terminated (terminated March 7, 2019). Affected quantity: 205.

Recall Details

Product Type
Devices
Report Date
May 17, 2017
Initiation Date
April 23, 2017
Termination Date
March 7, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
205

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).

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.

Distribution Pattern

US Distribution to the state of : TX

Code Information

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

Other recalls by Greatbatch Medical

  • Z-2782-2017 Class II — Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small cu (February 15, 2017)
  • Z-2781-2017 Class II — ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 (November 11, 2016)
  • Z-1190-2017 Class II — Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable (October 19, 2016)
  • Z-0623-2017 Class II — Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Co (September 8, 2016)
  • Z-0367-2017 Class I — Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl06 (August 2, 2016)
  • Z-1883-2016 Class II — Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non (April 26, 2016)
  • Z-1884-2016 Class II — Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed b (April 26, 2016)
  • Z-1882-2016 Class II — Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Cus (April 26, 2016)
  • Z-1614-2014 Class II — Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Orde (April 28, 2014)
  • Z-1119-2014 Class I — Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, (January 31, 2014)

FDA data resources