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Class 2 Device Recall Compress Short Anchor Plug Holder 13mm |
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Date Initiated by Firm |
July 18, 2008 |
Date Posted |
January 07, 2009 |
Recall Status1 |
Terminated 3 on July 07, 2009 |
Recall Number |
Z-0521-2009 |
Recall Event ID |
49014 |
510(K)Number |
K043547)
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Product Classification |
Orthopedic Manual Surgical Instrument - Product Code LXH
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Product |
Compress Short Anchor Plug Holder, 13mm, Biomet Orthopedics, Inc., Warsaw, IN; REF CP461038.
Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery. |
Code Information |
Lot 991680. |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46581-0587
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For Additional Information Contact |
800-348-9500 Ext. 3983
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Manufacturer Reason for Recall |
The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.
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FDA Determined Cause 2 |
Process control |
Action |
Distributors were notified via an Urgent Medical Device Removal Notice, dated 7/18/08, which instructed them to locate and remove the instruments, carefully follow the instructions on the enclosed "FAX Back Response Form," fax a copy of the Response Form to 574-372-1683 prior to return of product, and to notify the hospital personnel via a copy of a recall letter. The letter also stated that the instruments would be reworked and returned to the distributors. Distributors are to confirm receipt of the notice by calling, 800-348-9500, ext 3983. Questions related to the notice should be directed to Mary Hardesty at 800-348-9500 or 574-372-3983. |
Quantity in Commerce |
41 of all products. |
Distribution |
Worldwide Distribution --- including USA and countries of Australia, Belgium and Finland. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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