Date Initiated by Firm |
March 27, 2009 |
Date Posted |
September 21, 2009 |
Recall Status1 |
Terminated 3 on September 23, 2009 |
Recall Number |
Z-2115-2009 |
Recall Event ID |
51725 |
510(K)Number |
K072161
|
Product Classification |
Intramedullary Fixation Rod and Accessories - Product Code HSB
|
Product |
Phoenix Cannulated Recon Screw; Ti-Cann PARTL THD Recon Screw Trauma Fixation Systems; Rx only Biomet Trauma, 100 Interpace Parkway, Parsippany, NJ 077054
Intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. |
Code Information |
Catalog number: 14-406110; Lot number 517350 |
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 |
51 |
Distribution |
Worldwide Distribution -- USA and Spain. |
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.
|
510(K) Database |
510(K)s with Product Code = HSB and Original Applicant = BIOMET MANUFACTURING CORP.
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