Recalls / —

—#37728

Product

Intuiitve Surgical da Vinci 8 mm EndoWrist Curved Scissors, in box. All lots. P/N 400178-01

FDA product code

LRW — Scissors, General, Surgical

Device class

Class 1

Medical specialty

General, Plastic Surgery

510(k) numbers

K021036

Affected lot / code info

FDA Device Listing Number R100529, Model Number 400178-01. 510(k) number K021036.

Why it was recalled

Blades on the scissor may break and separate from the main unit as a result of corrosion damage.

Root cause (FDA determination)

Other

Action the firm took

The firm has sent notification letters to its consignees on 03/09/2005. Consignees are requested to return the feedback form provided by Intuitive Surgical, via Federal Express.

Recalling firm

Firm

Intuitive Surgical, Inc.

Address

950 Kifer Rd, Sunnyvale, California 94086-5206

Distribution

Distribution pattern

The product was distributed to 84 medical facilities, located throughout the US and Switzerland, Belgium, Germany, Australia, Turkey and France.

Timeline

Recall initiated

2005-03-09

Posted by FDA

2005-04-22

Terminated

2005-05-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #37728. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.