FDAApril 23, 2017device
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).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
greatbatch medicalgreatbatch
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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