Recall Z-0943-2013— Smith & Nephew Inc

Name: FDA recall Z-0943-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-07

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew Inc, initiated 2013-02-07, terminated 2016-01-11. It names one FDA 510(k) clearance: K981529. Product: INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.. Reason: 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label..

Recalling firm: Smith & Nephew Inc
Classification: Class II
Status: Terminated
Initiated: 2013-02-07
Terminated: 2016-01-11
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K981529 — TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREWSmith & Nephew, Inc.·cleared 1998-07-09

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

INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.

Reason for recall

75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.

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