VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instru
FDA device recall Z-0397-06 · posted 2006-01-18 · Terminated
Recall details
- Recalling firm
- Plus Orthopedics USA
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 14
- Distribution
- Arizona, California, Colorado, Idaho, New York, Oklahoma, Texas, Utah, Wisconsin
- Date initiated
- 2005-12-02
- Date posted
- 2006-01-18
- Date terminated
- 2007-01-29
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VKS KNEE SYSTEM (K022204) | Plus Orthopedics | 2002-10-18 |