Z-0397-06

VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable...

Name: Z-0397-06 VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable...
Creator: Plus Orthopedics USA
Published: 2005-12-02
License: https://open.fda.gov/license/

Plus Orthopedics / initiated 2005-12-02 / Terminated / root cause: manufacturing process

FDA source

Plus Orthopedics USA began a recall of VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument) on 2005-12-02. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0397-06
Status: Terminated
Initiated: 2005-12-02
Posted: 2006-01-18
Terminated: 2007-01-29
Recalling firm: Plus Orthopedics
Product: VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument)
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Other
Action: 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.
Quantity in commerce: 14
Distribution: Arizona, California, Colorado, Idaho, New York, Oklahoma, Texas, Utah, Wisconsin
Product codes and lots: PI.79; PI.79/I; PI.79/IIII; PI.80; PI.80/III; PI.80/IIII; PI.80/IIIII

Product code JWH

K022204Class IIVks Knee SystemPlus Orthopedics / cleared 2002-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)