PlainRecalls
FDA Devices Moderate Class II Terminated

8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Reported: December 3, 2014 Initiated: November 3, 2014 #Z-0427-2015

Product Description

8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Reason for Recall

Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument.

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
509 - total all affected instruments
Distribution
US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled?
8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.. Recalled by Intuitive Surgical, Inc.. Units affected: 509 - total all affected instruments.
Why was this product recalled?
Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface degradation of the housing; and/or, accelerate mechanical wear of the instrument.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 3, 2014. Severity: Moderate. Recall number: Z-0427-2015.