Broach

Foundation Knee System Instrumentation, Tibial Broach Assembly.

Strike plate may dislodge from the broach stem handle during impaction of the device.

Zimmer TM-400 Broach Handle; Part No. 96-210-10001. The product is a surgical instrument for use in conjunction with Zimmer TM-400 Trabecular Metal implants du

The broach handle may fracture at the threaded tip during use, which would result in surgical intervention to retrieve the broach or the trial as the threaded tip fragment prevents attachment of another handle to retrieve the device.

Zimmer Nexgen Complete Knee Solution Fluted Stemmed Tibial Broach, Size 7, 8, nonsterile; REF 5997-61-07.

The surface finish inside of the broach is not to specification and the instrument may corrode if cleaned and sterilized according to instructions.

Rejuvenate Broach

Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.

Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T1

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.