Plus Orthopedics USA VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121
Brand
Plus Orthopedics USA
Lot Codes / Batch Numbers
Model Number: 0214612, Lot Number: 044159 No serial numbers
Products Sold
Model Number: 0214612, Lot Number: 044159 No serial numbers
Plus Orthopedics USA is recalling VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, S due to Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Labeling Error: The VKS PE Ultra-congruent insert package, may actually contain a Standard PE insert.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026