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.
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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