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U.S. Department of Health and Human Services

Class 2 Device Recall Linear Straight Broach Handle, (Rasp Handle) EZ Clean" Linear Broach Handle

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 Class 2 Device Recall Linear Straight Broach Handle, (Rasp Handle) EZ Clean" Linear Broach Handlesee related information
Date Initiated by FirmApril 23, 2017
Create DateMay 09, 2017
Recall Status1 Terminated 3 on March 07, 2019
Recall NumberZ-2055-2017
Recall Event ID 77120
Product Classification Broach - Product Code HTQ
ProductLinear 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).
Code Information Lot numbers : Linear Straight Broach Handle (Rasp Handle): 2988946, 3138186, 3185601, 3287315, 3300879, 3333172, 3433392, 3332697. EZ Clean" Linear Broach Handle: 3508491.
Recalling Firm/
Manufacturer		 Greatbatch Medical
2300 Berkshire Ln N
Plymouth MN 55441-4575
For Additional Information ContactPhyllis Piet-Hughes
763-951-8184
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionGreatbatch 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 Greatbatch Medical representative, or contact us at 1-763-951-8235, or e-mail us at fieldaction.center@integer.net. For further questions, please call (763) 951-8184.
Quantity in Commerce205
DistributionUS Distribution to the state of : TX
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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