Recall Z-0523-2014— Biomet, Inc.

Class II FDA medical device recall by Biomet, Inc., initiated 2013-11-26, terminated 2015-07-07. FDA's recall record names no specific 510(k) clearance for this event. Product: outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect label: CurvTek 7 MM Medium, Single Pack Quantity -3, REF 906760 To pass the CurvTek needle, place the jaws of the instrument utilized to grasp the needle on the sides of the needle and orient and needle parallel to the long axis of the instrument. Position the needle to follow the path of the tunnel created by the cartridges. This aligns the needle with the radius of the transosseous tunnel. Advance the needle while rotating the instrument away from the entry point. Gently feed the needle through the length of the tunnel.. Reason: Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium..

Recalling firm

Biomet, Inc.

Classification

Class II

Status

Terminated

Initiated

2013-11-26

Terminated

2015-07-07

Firm location

Warsaw, IN, United States

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