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Terminated

8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA

FDA Recall Z-0660-2007 · Posted 2007-03-28

Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2005-03-24
Date Terminated2007-11-28
Product Quantity8

Reason for Recall

The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.

Firm Action

The firm initiated its recall in March 24, 2005, when the firm sent a letter via Federal Express mail to all 18 consignees, informing them of the issue, how to identify affected product, and instructions to return the affected instruments for a full credit. The form included a reply form that consignees were requested to fill out and return.

Root Cause

Other

Distribution Pattern

Product was distributed to 12 consignees in the US, who received 19 instruments, in FL, IN, LA, MN, NC, NH, NJ, NY, TN and TX. In addition, 5 consignees outside the US received product as well, in Italy, Sweden, France, Singapore and Germany.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012833INTUITIVE SURGICAL BIPOLAR FORCEPSIntuitive Surgical, Inc. · 2001-11-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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