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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet KWire/Trocar Point

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  Class 2 Device Recall Biomet KWire/Trocar Point see related information
Date Initiated by Firm August 06, 2009
Date Posted November 19, 2009
Recall Status1 Terminated 3 on October 06, 2010
Recall Number Z-0367-2010
Recall Event ID 53580
Product Classification K-wire, Trocar Point - Product Code FZX
Product Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 35-351534.

Internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. The devices can also be used as instrument accessories to stabilize cut blocks and can serve as guide wires while using reamers.
Code Information Lot Number 087190.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information Contact
800-348-9500
Manufacturer Reason
for Recall		 Packages labeled as having a .045 inch diameter trocar point actually contain a diamond point with a diameter of .062 inches.
FDA Determined
Cause 2		 Process control
Action An "Urgent Medical Device Recall Notice" dated August 6, 2009 was issued to consignees. The letter described the affected product, issue and actions for consignees. Customers were instructed to complete and return the "FAX back Response Form" (fax number 1-574-372-1683) and all affected product in inventory to Biomet Orthopedics. Direct questions related to the recall notification by calling at 1-800-348- 9500 or 1-574-372-3983, Monday through Friday, 8AM to 5PM.
Quantity in Commerce 19
Distribution United States (Florida and Pennsylvania).
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.
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