Recall Z-2055-2017— Greatbatch Medical
Class II · Terminated
Class II FDA medical device recall by Greatbatch Medical, initiated 2017-04-23, terminated 2019-03-07. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Greatbatch Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-23
- Terminated
- 2019-03-07
- Firm location
- Plymouth, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.