Pathfinder End Screw Extender Sleeve, REF 1165-10, Rx, non-sterile, sold under label Abbott Spine, Inc. Austin TX (prior to 2008) and Zimmer Spine Austin TX (7/2009 to present)
FDA Recall Z-0075-2011 · Posted 2010-10-18
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeNKB
Date Initiated2010-04-13
Date Terminated2012-02-10
Product Quantity1471 (888 subject to removal)
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.
Firm Action
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
Distribution Pattern
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, Cyprus, France, Germany, Greece, Italy, Japan, Mexico, Thailand, Turkey, UK and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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