EBI Trochanteric 11mm Long Nail.
FDA device recall Z-0012-06 · posted 2005-10-07 · Terminated
Recall details
- Recalling firm
- EBI, L.P.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JDS
- Quantity affected
- 102 nails
- Distribution
- There are 9 sales representatives that are instructed to remove and return the EBI nail from nationwide customers.
- Date initiated
- 2005-06-24
- Date posted
- 2005-10-07
- Date terminated
- 2006-07-03
- Location
- Parsippany, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EBI TROCHANTERIC NAIL SYSTEM (K050118) | Ebi, L.P. | 2005-02-16 |