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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 24, 2005
Date Posted October 07, 2005
Recall Status1 Terminated 3 on July 03, 2006
Recall Number Z-0012-06
Recall Event ID 32813
510(K)Number K050118  
Product Classification Nail, Fixation, Bone - Product Code JDS
Product EBI Trochanteric 11mm Long Nail.
Code Information Catalog No./Lot Nos: 28226/164522; 28228/164523; 28230/175576; 28234/175583; 28238/175589; 28248/164527; 28324/164529; 28326/164531; 28328/164532; 28330/175614; 28332/170182; 28334/175621; 28338/175630; 28342/166415; 28344/164540; 28348/164545.
Recalling Firm/
Manufacturer		 EBI, L.P.
100 Interpace Pkwy
Parsippany NJ 07054-1149
For Additional Information Contact Whitney Torning
973-299-9300 Ext. 3964
Manufacturer Reason
for Recall		 Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.
FDA Determined
Cause 2		 Other
Action The firm sent out via e-mail notification to their field representatives on 6/27/2005 to identify, remove and return to EBI all affected product from their inventories. One direct customer, Dr. Maylack was sent a recall letter on 7/7/2005.
Quantity in Commerce 102 nails
Distribution There are 9 sales representatives that are instructed to remove and return the EBI nail from nationwide customers.
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 = JDS and Original Applicant = EBI, L.P.
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