Recall Z-0360-2008 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Plus Orthopedics USA
Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics USA, San Diego, CA 92121
| Date | Dec 8, 2007 (initiated Jun 30, 2003) |
| Status | Terminated |
| Reason | The device was produced without the required distal locking hole |
| Root cause | Reprocessing Controls |
| Action | 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. |
| Quantity | 3 |
| Distribution | Nationwide: AZ and ID |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020240 | SLIM GLIDING NAIL SYSTEM Plus Orthopedics, Feb 22, 2002 |