FDA Medical Device Recalls (openFDA)
Zimmer Inc.: 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)
- Recall number
- Z-0075-2011
- Recalling firm
- Zimmer Inc.
- Product
- 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)
- Status
- Terminated
- Initiated
- 2010-04-13
- Posted
- 2010-10-18
- Terminated
- 2012-02-10
- Reason
- 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.
- Root cause
- Device Design
- 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.
- Quantity
- 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, Cyprus, France, Germany, Greece, Italy, Japan, Mexico, Thailand, Turkey, UK and Switzerland.
- Lot, serial or model codes
- 20XH, 21SM, 25WG, 29CS, 29YL, 31TL, 32SQ, 33ZK, 34LG, 34XW, 35JW, 36WE, 39BH, 43MP, 44WR, 47EX, 48GF, 48LM, 48MB, 50GD and 50GE.
- 510(k) numbers
- ["K030625","K071174"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28