Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics U
FDA device recall Z-0360-2008 · posted 2007-12-08 · Terminated
Recall details
- Recalling firm
- Plus Orthopedics USA
- Reason for recall
- The device was produced without the required distal locking hole
- Action taken
- The initial depth of the withdrawal action taken in June, 2003 ,was to the distributor (agent) level. Plus USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA.
- Root cause
- Reprocessing Controls
- Status
- Terminated
- Product code
- KTT
- Quantity affected
- 3
- Distribution
- Nationwide: AZ and ID
- Date initiated
- 2003-06-30
- Date posted
- 2007-12-08
- Date terminated
- 2007-12-13
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SLIM GLIDING NAIL SYSTEM (K020240) | Plus Orthopedics | 2002-02-22 |