• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Compress Instrument Anchor Plug Holder

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Compress Instrument Anchor Plug Holder see related information
Date Initiated by Firm July 18, 2008
Date Posting Updated January 07, 2009
Recall Status1 Terminated 3 on July 07, 2009
Recall Number Z-0517-2009
Recall Event ID 49014
510(K)Number K043547)  
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Compress Instrument Anchor Plug Holder, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-481006.

Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.
Code Information Lots 913020 and 306010.
Recalling Firm/
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581-0587
For Additional Information Contact
800-348-9500 Ext. 3983
Manufacturer Reason
for Recall
The set screw may not fully seat, which will prevent the handle from mating to the instrument during use.
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

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.