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U.S. Department of Health and Human Services

Class 2 Device Recall TX 8 Driver

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 Class 2 Device Recall TX 8 Driversee related information
Date Initiated by FirmApril 14, 2009
Date PostedJune 26, 2009
Recall Status1 Terminated 3 on September 24, 2010
Recall NumberZ-1524-2009
Recall Event ID 52031
510(K)NumberK022324 K022325 
Product Classification Orthopedic Manual Surgical Instrument - Product Code HXX
ProductNormed 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.
Code Information Lot #145B08
Recalling Firm/
Manufacturer		 Ascension Orthopedics, Inc
8700 Cameron Rd Ste 100
Austin TX 78754
For Additional Information Contact
512-836-5001 Ext. 1513
Manufacturer 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.
FDA Determined
Cause 2		Pending
ActionFirm notified their distributors of recall via phone starting 04/14/09. Distributors replaced the recalled screwdrivers with ones that were manufactured to specification.
Quantity in Commerce9 units.
DistributionNationwide Distribution -- including states of CO, OR, and TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HXX
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