Z-0361-2008
VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego...
Plus Orthopedics / initiated 2006-11-13 / Terminated / root cause: manufacturing process
Plus Orthopedics USA began a recall of VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121 on . The reason FDA records is "Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0361-2008
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Plus Orthopedics
- Product
- VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121
- Product code
- JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Reason for recall
- Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert.
- Root cause tag
- manufacturing process
- FDA root cause
- Employee error
- Action
- Consignees were notified by telephone on 11/13/2006 to check their inventory and return any affected units. On 11/28/06 Physician Notifications and Patient Assessment forms were sent to the two physicians who had implanted a total of 4 devices.
- Quantity in commerce
- 10
- Distribution
- Nationwide: USA including states of ID, NY, VA & WI
- Product codes and lots
- Model Number: 0214612, Lot Number: 044159 No serial numbers
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