FDA Device

VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121

Hazard

Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert.

What You Should Do

Remedy

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.

Products

VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121
Brand
Plus Orthopedics USA
UPC
Model Number: 0214612, Lot Number: 044159 No serial numbers

Units Affected

10