FDA Recall Terminated

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

Recall: Z-0723-05 · Initiated March 9, 2005

Recall

Recall Number
Z-0723-05
Event Number
31360
Firm
Intuitive Surgical, Inc.
FEI Number
3001675293
Product Code
LRW
Status
Terminated
Root Cause
Other
Initiated
March 9, 2005
Posted
April 22, 2005
Terminated
May 13, 2005
Address
950 Kifer Rd, Sunnyvale, CA, 94086-5206

Description

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

Reason

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

Action

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.

Distribution

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

Quantity

278 units have been distributed.