Z-1208-2009

Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant surgery. REF: DC4261...

Name: Z-1208-2009 Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant surgery. REF: DC4261...
Creator: Wright Medical Technology Inc
Published: 2009-02-19
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2009-02-19 / Terminated / root cause: manufacturing process

FDA source

Wright Medical Technology Inc began a recall of Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant surgery. REF: DC4261, Non-sterile, Rx only, 1 each, Wright Medical... on 2009-02-19. The reason FDA records is "The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam sterilization is validated". 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-1208-2009
Status: Terminated
Initiated: 2009-02-19
Posted: 2009-04-28
Terminated: 2010-02-03
Recalling firm: Wright Medical Technology Inc
Product: Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant surgery. REF: DC4261, Non-sterile, Rx only, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam sterilization is validated.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Wright Medical notified their distributors of the recall on 03/11/2009 by letter explaining the problem and requesting return of the product from their inventory and from their consignees. The letter included a "fax back" response page to ensure the receipt of the notice. The hospitals and surgeons were notified of the recall also on 03/11/2009. All letters were delivered by Fed Ex.
Quantity in commerce: 682 devices
Distribution: Worldwide distribution: USA, Canada, Germany, France, Belgium, the Netherlands, Italy, Finland, Austria, Denmark, Norway, Turkey, South Africa, United Kingdom, and Australia.
Product codes and lots: Lot numbers: 019598209, 038504328, 058486628, 058507733, 058516752, 067422530, 088538652, 098538652, 107439501, 107442247, 117442247, 0712180, S0701050

Product code LXH

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)