Recall Z-2055-2017 ยท HTQ Broach
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).
| Date | Apr 23, 2017 |
| Status | Terminated |
| 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 Grea |
| Quantity | 205 |
| Distribution | US Distribution to the state of : TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.