Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0360-2008

Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus...

Plus Orthopedics / initiated 2003-06-30 / Terminated

Plus Orthopedics USA began a recall of Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics USA, San Diego, CA 92121 on . The reason FDA records is "The device was produced without the required distal locking hole". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0360-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Plus Orthopedics
Product
Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics USA, San Diego, CA 92121
Product code
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall
The device was produced without the required distal locking hole
FDA 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 in commerce
3
Distribution
Nationwide: AZ and ID
Product codes and lots
Model Number: 0132073, Lot Number : 024332