| Date Initiated by Firm |
March 16, 2005 |
| Date Posted |
June 22, 2005 |
| Recall Status1 |
Terminated 3 on June 30, 2006 |
| Recall Number |
Z-0917-05 |
| Recall Event ID |
31822 |
| Product Classification |
Passer, Wire, Orthopedic - Product Code HXI
|
| Product |
EBI Ball Tip Guide Wire 3.2mm x 98cm found in the Holland Nail Flexible Reamer Accessory P/N 469060. |
| Code Information |
Lot Numbers: 130843; 130846. |
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 |
167 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
|
|
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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