EBI Ball Tip Guide Wire 3.2mm x 98cm found in the Holland Nail Flexible Reamer Accessory P/N 469060.
FDA device recall Z-0917-05 · posted 2005-06-22 · Terminated
Recall details
- Recalling firm
- EBI, L.P.
- 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.
- Action taken
- The firm distributed a recall letter to their EBI Fracture Sales Representatives and their EBI Trauma Distributors on 3/16/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- HXI
- Quantity affected
- 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 S
- Date initiated
- 2005-03-16
- Date posted
- 2005-06-22
- Date terminated
- 2006-06-30
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.