Date Initiated by Firm | March 16, 2005 |
Date Posted | June 22, 2005 |
Recall Status1 |
Terminated 3 on June 30, 2006 |
Recall Number | Z-0918-05 |
Recall Event ID |
31822 |
510(K)Number | K982953 |
Product Classification |
Passer, Wire, Orthopedic - Product Code HXI
|
Product | Threaded 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. |
Recalling Firm/ Manufacturer |
EBI, L.P. 100 Interpace Pkwy Parsippany NJ 07054-1149
|
For Additional Information Contact | James 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 |
Action | The firm distributed a recall letter to their EBI Fracture Sales Representatives and their EBI Trauma Distributors on 3/16/2005. |
Quantity in Commerce | 152 units |
Distribution | These 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 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.
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510(K) Database | 510(K)s with Product Code = HXI
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