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U.S. Department of Health and Human Services

Class 2 Device Recall CurvTek Eye Needle

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 Class 2 Recall
CurvTek Eye Needle
see related information
Date Posted December 17, 2013
Recall Status1 Open
Recall Number Z-0523-2014
Recall Event ID 66964
Product Classification Forceps - Product Code HTD
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.
Code Information Lot 055450
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
For Additional Information Contact Audrey Daenzer
574-372-1570
Manufacturer Reason
for Recall
Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Biomet sent an Urgent Medical Device Recall Notice dated November 26, 2013, to all affected customers. The notice identifies the product, problem, and actions to be taken by the customers. The letter included a Customer Response Form for customers to complete and return to the firm by FAX 574-372-1683. Customers with questions were instructed to call 574-372-1570. For questions regarding this recall call 574-372-1570.
Quantity in Commerce 21
Distribution Nationwide Distribution including MI, IA, IL, IN, and TN.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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