Z-1485-2012

VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, Wright Medical Technology, Inc., 5677 Airline, Road...

Name: Z-1485-2012 VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, Wright Medical Technology, Inc., 5677 Airline, Road...
Creator: Wright Medical Technology Inc
Published: 2012-04-05
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2012-04-05 / Terminated / root cause: design

FDA source

Wright Medical Technology Inc began a recall of VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The VALOR" Ankle Fusion Nail... on 2012-04-05. The reason FDA records is "The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1485-2012
Status: Terminated
Initiated: 2012-04-05
Posted: 2012-05-02
Terminated: 2013-01-28
Recalling firm: Wright Medical Technology Inc
Product: VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcots Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.
Root cause tag: design
FDA root cause: Device Design
Action: Wright Medical Technology, Inc. sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated April 2, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to check their stock and to return the affected product to the firm. Additionally, a Product Recall Verification Form was enclosed for customers to complete and return via fax to 901-867-7401. Contact the firm at 901-867-4324 for questions regarding this notice.
Quantity in commerce: 133 units
Distribution: Worldwide Distribution-USA (nationwide) and the country of Australia.
Product codes and lots: all lots distributed until 03/9/2012

Product code HSB

K090857Class IIValor Ankle Fusion Nail SystemWrightmedicaltechnologyinc / cleared 2009-07-14

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)