Z-2055-2017Class II

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

Name: Z-2055-2017 Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and...
Creator: Greatbatch Medical
Published: 2017-04-23
License: https://open.fda.gov/license/

Greatbatch Medical / initiated 2017-04-23 / Terminated / root cause: manufacturing process

FDA source

Greatbatch Medical began a recall of Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part #... on 2017-04-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2055-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-23
Posted: 2017-05-09
Terminated: 2019-03-07
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).
Product code: HTQ Broach
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 [email protected]. For further questions, please call (763) 951-8184.
Quantity in commerce: 205
Distribution: US Distribution to the state of : TX
Product codes and lots: Lot numbers : Linear Straight Broach Handle (Rasp Handle): 2988946, 3138186, 3185601, 3287315, 3300879, 3333172, 3433392, 3332697. EZ Clean" Linear Broach Handle: 3508491.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2055-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2055-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-17	2017-05-09

Product code HTQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)