Recall Z-2199-2013— Tornier, Inc

Class II FDA medical device recall by Tornier, Inc, initiated 2013-08-13, terminated 2015-03-03. FDA's recall record names no specific 510(k) clearance for this event. Product: AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025. The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the glenoid sphere, poly insert, spacer, and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly.. Reason: Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors. Upon review of the event, Tornier determined that a redesign of the instrument was warranted. These products are contained within the Aequalis Revered II instrument set tray no YKAD83 and the Aequalis R.

Recalling firm

Tornier, Inc

Classification

Class II

Status

Terminated

Initiated

2013-08-13

Terminated

2015-03-03

Firm location

Bloomington, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.