Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label Abbott Spine, Inc. Austin TX (prior

FDA device recall Z-0075-2011 · posted 2010-10-18 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

The tip of the PathFinder End Screw Extender Sleeve has fractured during use. In some cases, this instrument fracture led to surgical delay or additional surgical steps necessary to remove the fragments of the broken tip.

Action taken

Zimmer Spine issued an "Urgent Medical Device Correction" letter through the Zimmer Spine sales force to be provided to PathFinder system users in February 2010. the letter identified the affected product, safety issue, and actions to be taken by customers. Customers will receive replacement devices with a design change for the recalled devices, as they are available from the manufacturer.

Root cause

Device Design

Status

Terminated

Product code

NKB

Quantity affected

1471 (888 subject to removal)

Distribution

Worldwide Distribution: USA including states of AZ, CA, CO, FL, GA, LA, MI, MN, MO, NC, NH, NY, OH, OK, PA, TN, TX, WA, and WI, and the countries of Australia, Belgium, Brazil, Canada, China, Colombia

Date initiated

2010-04-13

Date posted

2010-10-18

Date terminated

2012-02-10

Location

Warsaw, IN

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