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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmMarch 16, 2005
Date PostedJune 22, 2005
Recall Status1 Terminated 3 on June 30, 2006
Recall NumberZ-0918-05
Recall Event ID 31822
510(K)NumberK982953 
Product Classification Passer, Wire, Orthopedic - Product Code HXI
ProductThreaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640.
Code Information Lot Numbers:  065882; 122235; 132557; 132560; 877265.
FEI Number 2242816
Recalling Firm/
Manufacturer		 EBI, L.P.
100 Interpace Pkwy
Parsippany NJ 07054-1149
For Additional Information ContactJames Pastena
973-299-9300 Ext. 3302
Manufacturer Reason
for Recall		The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.
FDA Determined
Cause 2		Other
ActionThe firm distributed a recall letter to their EBI Fracture Sales Representatives and their EBI Trauma Distributors on 3/16/2005.
Quantity in Commerce152 units
DistributionThese devices are distributed nationwide to sales representatives who provide the product directly to the hospital/physician at the time of the surgery. The product was also distributed to Italy and Spain. There are no government accounts.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HXI
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