Recall Z-0373-2016— Smith & Nephew, Inc.

Name: FDA recall Z-0373-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-20

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2015-10-20, terminated 2016-09-21. It names one FDA 510(k) clearance: K083032. Product: Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate. Reason: The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-10-20
Terminated: 2016-09-21
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K083032 — PERI-LOC BONE PLATING AND SCREW SYSTEMSmith & Nephew, Inc.·cleared 2009-01-07

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 PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixation plate

Reason for recall

The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates.

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