Recall Z-0097-2018— Smith & Nephew, Inc.

Name: FDA recall Z-0097-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-24

Class II · Ongoing

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2017-10-24. It names one FDA 510(k) clearance: K040212. Product: smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL. Reason: A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2017-10-24
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K040212 — TRIGEN INTERTANSmith & Nephew, Inc.·cleared 2004-02-20

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

smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL

Reason for recall

A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.

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