Recall Z-1376-2018— Wright Medical Technology, Inc.

Name: FDA recall Z-1376-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-14

Class II · Terminated

Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2018-03-14, terminated 2020-10-05. It names one FDA 510(k) clearance: K090857. Product: WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R. Reason: Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw..

Recalling firm: Wright Medical Technology, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-03-14
Terminated: 2020-10-05
Firm location: Arlington, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K090857 — VALOR ANKLE FUSION NAIL SYSTEMWrightmedicaltechnologyinc·cleared 2009-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw.

Data sourced from openFDA. This site is unofficial and independent of the FDA.