FDA Medical Device Recalls (openFDA)
Greatbatch Medical: 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).
- Recall number
- Z-2055-2017
- Recalling firm
- Greatbatch Medical
- Product
- 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).
- Status
- Terminated
- Initiated
- 2017-04-23
- Posted
- not on file
- Terminated
- 2019-03-07
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- Greatbatch sent an Urgent Medical Device Recall letter dated April 23, 2017. The letter described the product being recalled and described Reason For Recall, Risk To Health, Replacement Devices, & Instructions to DJO Surgical Inc. Advised consignee to quarantine and return the affected product. If the product was further distributed they should contact the end users and share the recall information with them. Requested consignees to complete and return the "Field Recall Response Form" to Stericycle at Greatbatch4053@stericycle.com or fax it to 877-479-8063. For questions contact your Greatbatch Medical representative, or contact us at 1-763-951-8235, or e-mail us at fieldaction.center@integer.net. For further questions, please call (763) 951-8184.
- Quantity
- 205
- Distribution
- US Distribution to the state of : TX
- Lot, serial or model codes
- Lot numbers : Linear Straight Broach Handle (Rasp Handle): 2988946, 3138186, 3185601, 3287315, 3300879, 3333172, 3433392, 3332697. EZ Clean" Linear Broach Handle: 3508491.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTQ
- Firm FEI
- 2183787
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28