Recall Z-2685-2020— Smith & Nephew, Inc.

Name: FDA recall Z-2685-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-24

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2020-06-24, terminated 2021-04-28. It names one FDA 510(k) clearance: K061019. Product: TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.. Reason: A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-06-24
Terminated: 2021-04-28
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K061019 — TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILSSmith & Nephew, Inc.·cleared 2006-06-06

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

TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place.

Reason for recall

A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.

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