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Recall Observatory FDA recall evidence

Device 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).

Z-2055-2017

April 23, 2017

Class II

Product summary

Firm
Greatbatch Medical
Event
Event 77120
Status
Terminated
Classification
Class II
Quantity
205
Official record key
device-enforcement:Z-2055-2017

Official wording

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.

Code information: Lot numbers : Linear Straight Broach Handle (Rasp Handle): 2988946, 3138186, 3185601, 3287315, 3300879, 3333172, 3433392, 3332697. EZ Clean" Linear Broach Handle: 3508491.

Distribution pattern: US Distribution to the state of : TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.