PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727.

FDA device recall Z-1784-2008 · posted 2008-09-05 · Terminated

Recall details

Recalling firm

Abbott Spine

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

NKB

Quantity affected

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, B

Date initiated

2008-04-17

Date posted

2008-09-05

Date terminated

2009-12-02

Location

Austin, TX

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