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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description 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.
Recall Number Z-0523-2014
Classification Class II
Code Info Lot 055450
Product Distributed Qty 21
Reason For Recall Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.

Event Detail

Event Id 66964
Product Type Devices
Status Ongoing
Recalling Firm Biomet, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern hospitals MI, IA, IL, IN, TN