Linear Straight Broach Handle — Class II medical device recall Z-2055-2017
Terminated recall by Greatbatch Medical, reported 2017-05-17, distributed in TX. Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp Handle) and
| Recall number | Z-2055-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Greatbatch Medical, Plymouth, MN, United States |
| Recall initiated | 2017-04-23 |
| Classified | 2017-05-09 |
| Reported by FDA | 2017-05-17 |
| Terminated | 2019-03-07 |
| Distributed | TX |
| Quantity | 205 |
| Model numbers | 510397, T11824 |
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).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2055-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.