VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument)
FDA Recall Z-0397-06 · Posted 2006-01-18
Recalling FirmPlus Orthopedics USA
Recall StatusTerminated
Product CodeJWH
Date Initiated2005-12-02
Date Terminated2007-01-29
Product Quantity14
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Arizona, California, Colorado, Idaho, New York, Oklahoma, Texas, Utah, Wisconsin
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.