FDA Medical Device Recalls (openFDA)
Plus Orthopedics USA: VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument)
- Recall number
- Z-0397-06
- Recalling firm
- Plus Orthopedics USA
- Product
- VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument)
- Status
- Terminated
- Initiated
- 2005-12-02
- Posted
- 2006-01-18
- Terminated
- 2007-01-29
- Reason
- 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
- 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
- 14
- Distribution
- Arizona, California, Colorado, Idaho, New York, Oklahoma, Texas, Utah, Wisconsin
- Lot, serial or model codes
- PI.79; PI.79/I; PI.79/IIII; PI.80; PI.80/III; PI.80/IIII; PI.80/IIIII
- 510(k) numbers
- ["K022204"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3001237832
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28