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Terminated

Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascension Orthopedics, Inc., Austin, TX 78754. Orthopedic manual surgical screwdriver.

FDA Recall Z-1524-2009 · Posted 2009-06-26

Recalling FirmAscension Orthopedics, Inc
Recall StatusTerminated
Product CodeHXX
Date Initiated2009-04-14
Date Terminated2010-09-24
Product Quantity9 units.

Reason for Recall

Screwdriver used with the Ascension Total Foot System not manufactured to specification, resulting in the driver not properly engaging and/or stripping the screws making it difficult to properly seat the screws during surgery.

Firm Action

Firm notified their distributors of recall via phone starting 04/14/09. Distributors replaced the recalled screwdrivers with ones that were manufactured to specification.

Root Cause

Pending

Distribution Pattern

Nationwide Distribution -- including states of CO, OR, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022324NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEMOsteomedics, Inc. · 2002-09-17K022325NORMED TITANIUM OSTEOTOMY PLATING SYSTEMOsteomedics, Inc. · 2002-09-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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