Recall Z-1636-2014— Smith & Nephew Inc

Name: FDA recall Z-1636-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-04

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew Inc, initiated 2014-04-04, terminated 2017-07-01. It names one FDA 510(k) clearance: K040212. Product: TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF 71675207, 10 MM X 18 CM, 130 degree, (7) REF 71675208, 11.5 MM X 18 CM, 130 degree, (8) REF 71675211, 11.5 MM X 20 CM, 130 degree, Smith & Nephew, Inc. Orthopedic fixation device.. Reason: A manufacturing error resulted in the set screw being inserted too deep in the affected nails..

Recalling firm: Smith & Nephew Inc
Classification: Class II
Status: Terminated
Initiated: 2014-04-04
Terminated: 2017-07-01
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

TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF 71675207, 10 MM X 18 CM, 130 degree, (7) REF 71675208, 11.5 MM X 18 CM, 130 degree, (8) REF 71675211, 11.5 MM X 20 CM, 130 degree, Smith & Nephew, Inc. Orthopedic fixation device.

Reason for recall

A manufacturing error resulted in the set screw being inserted too deep in the affected nails.

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