Plus Orthopedics USA VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument)
Brand
Plus Orthopedics USA
Lot Codes / Batch Numbers
PI.79, PI.79/I, PI.79/IIII, PI.80, PI.80/III, PI.80/IIII, PI.80/IIIII
Products Sold
PI.79; PI.79/I; PI.79/IIII; PI.80; PI.80/III; PI.80/IIII; PI.80/IIIII
Plus Orthopedics USA is recalling VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-u due to The adjustment knob tower on one device was found to have broken off from the body of the instrument. This did not happend during a surgery and is be. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The adjustment knob tower on one device was found to have broken off from the body of the instrument. This did not happend during a surgery and is believed to have been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.
Recommended Action
Per FDA guidance
The adjustment know tower on one device was found t have broken off from the body of the instrument. This did not happend during a surgery, and is belived tohave been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.
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 noticeDistribution
As reported by FDA
AZ, CA, CO, ID, NY, OK, TX, UT, WI
Page updated: Jan 10, 2026