Z-2470-2010

DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1 EACH, Rx ONLY...

Name: Z-2470-2010 DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1 EACH, Rx ONLY...
Creator: Wright Medical Technology Inc
Published: 2010-08-26
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2010-08-26 / Terminated / root cause: manufacturing process

FDA source

Wright Medical Technology Inc began a recall of DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1 EACH, Rx ONLY, NON-STERILE, EC REP Wright Medical EMEA, Krijgsman 11... on 2010-08-26. The reason FDA records is "After autoclaving, the epoxy identifier (colored) band bled and there is concern that it may flake". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2470-2010
Status: Terminated
Initiated: 2010-08-26
Posted: 2010-09-22
Terminated: 2012-08-02
Recalling firm: Wright Medical Technology Inc
Product: DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1 EACH, Rx ONLY, NON-STERILE, EC REP Wright Medical EMEA, Krijgsman 11, 1186 DM Amstelveen, The Netherlands, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002
Product code: HXX Screwdriver
Reason for recall: After autoclaving, the epoxy identifier (colored) band bled and there is concern that it may flake.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm initiated their recall the product by letter on 08/26/2010. The letters were addressed to distributors and hospital administrators with a fax back response form. Please contact Customer Service at 800-238-7117, if you have any questions.
Quantity in commerce: 13 units
Distribution: TX, PA, TN, VA, GA, and Spain
Product codes and lots: Lot number 040754491

Product code HXX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)