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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AZ, AR, CA, CO, CT, FL, IL, MD, MI, MO, MT, NV, NJ, NM, NY, NC, OH, OK, PA, SD, TX, WI