Class 2 Device Recall PERILOC Volar Distal Radius 3 Hole Plate

• Date Initiated by Firm: October 20, 2015
• Date Posted: December 04, 2015
• Recall Status: Terminated on September 21, 2016
• Recall Number: Z-0373-2016
• Recall Event ID: 72655
• 510(K)Number: K083032
• Product Classification: Plate, fixation, bone - Product Code HRS
• 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
• Code Information: Batch # 14KT47575
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 1450 E Brooks Rd; Memphis TN 38116-1804
• For Additional Information Contact: Joe Metzger; 978-749-1330
• Manufacturer 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.
• FDA Determined Cause: Employee error
• Action: Distributors, notified by Fed- Ex on 10/20/2015, were asked to quarantine the product and return it.
• Quantity in Commerce: 9 units
• Distribution: International only Germany, Japan, Russia
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HRS and Original Applicant = SMITH & NEPHEW, INC.