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
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