FDA-Device2017-05-17Class II
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).
Greatbatch Medical
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.
Sold states
US Distribution to the state of : TX
Affected count
205
Manufactured in
2300 Berkshire Ln N, N/A, Plymouth, MN, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2055-2017Don't want to check this manually?
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