Class 2 Device Recall Bone Awl

• Date Initiated by Firm: April 17, 2008
• Date Posted: September 05, 2008
• Recall Status: Terminated on December 02, 2009
• Recall Number: Z-1784-2008
• Recall Event ID: 47869
• 510(K)Number: K030625 K071174
• Product Classification: Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
• Product: PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727.
• Code Information: All lots.
• FEI Number: 3000718496
• Recalling Firm/ Manufacturer: Abbott Spine; 12708 Riata Vista Cir # B-100; Austin TX 78727-7167
• For Additional Information Contact: 512-918-2700
• Manufacturer Reason for Recall: Breakage - Tips on the Pathfinder Bone Awl may bend or break prematurely. The firm has received internal non-conformances and complaints where the tips of the Awl were worn and damaged. Of the tip breaks, six have had material missing. During the same period, there were 15 complaints reported where the tip broke off at the weld after repeated use (1-3 years). The firm found several possible ca
• FDA Determined Cause: Device Design
• Action: Phone calls and emails were used to disseminate information about this recall. Firm notified consignees via telephone beginning on 04/17/08. Consignees were told that some problems were found through normal wear and tear as well as product mis-use and material weaknesses. The firm explained that they noticed from wear and tear from use as well as damage from use could cause the tip to become dull and flared causing breakage. The firm explained that they redesigned the awl and requested that consignees return outstanding inventory, which will be replaced with a new version of the awl.
• Quantity in Commerce: 180 units.
• Distribution: Class II Recall - Worldwide Distribution --- USA including states of AR, AZ, CA, CT, CO, FL, IL, MD, MI, MO, MT, NC, NJ, NV, NY, NM, OH, OK, PA, SD, TX and WI, and countries of Argentina, Australia, Belgium, Canada, China, Columbia, Cyprus, Germany, Greece, Italy, Japan, Mexico, Thailand, Turkey and UK/Ireland.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NKB; 510(K)s with Product Code = NKB