Z-1376-2018Class II

WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R

Name: Z-1376-2018 WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R
Creator: Wright Medical Technology, Inc.
Published: 2018-03-14
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2018-03-14 / Terminated

FDA source

Wright Medical Technology, Inc. began a recall of WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R on 2018-03-14. FDA classified it as Class II and gives the reason as "Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1376-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-14
Posted: 2018-04-13
Terminated: 2020-10-05
Recalling firm: Wright Medical Technology Inc
Product: WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.
FDA root cause: Under Investigation by firm
Action: Firm initiated the recall on 03/14/2018 by email communication to distribution centers and distributor consignees, along with a field note to all sales representatives. The firm requested return of the product.
Quantity in commerce: 50 units
Distribution: US and Argentina, Belgium, Brazil, Chile, Colombia, Germany, Italy, Mexico, Peru, Thailand, and United Kingdom
Product codes and lots: Lot 1610957

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1376-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1375-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-13
Z-1376-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-13

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)