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U.S. Department of Health and Human Services

Class 3 Device Recall Uniflex Ti Buttress Thread Screw

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  Class 3 Device Recall Uniflex Ti Buttress Thread Screw see related information
Date Initiated by Firm March 27, 2009
Date Posted September 21, 2009
Recall Status1 Terminated 3 on September 23, 2009
Recall Number Z-2116-2009
Recall Event ID 51725
510(K)Number K982953  
Product Classification Intramedullary Fixation Rod and Accessories - Product Code HSB
Product Uniflex Ti Buttress Thread Screw;
TI Screw Buttress Thread
Trauma Fixation Systems, Rx only
Biomet, 100 Interpace Parkway, Parsippany, NJ 07054

Intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred.
Code Information Catalog number: 33-345532; Lot number 598990
Recalling Firm/
Manufacturer		 EBI, L.P.
100 Interpace Pkwy
Parsippany NJ 07054-1149
For Additional Information Contact William Hennig
973-299-9300 Ext. 3904
Manufacturer Reason
for Recall		 Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Letters to Biomet/EBI reps were sent on March 29, 2009 by US mail to alert them of the product recall and the affected parts that may be in their possession. They were also asked to notify each customer and locate all affected inventory. All letters advised of the recall and the specific lot numbers involved. A letter was sent to the hospital and physician that received affected parts and asked that implanting physicians make any medical decisions.
Quantity in Commerce 5
Distribution Worldwide Distribution -- USA and Spain.
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.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = BIOMET, INC.
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