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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew PERILOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE

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  Class 2 Device Recall Smith & Nephew PERILOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE see related information
Date Initiated by Firm October 20, 2015
Date Posted December 04, 2015
Recall Status1 Terminated 3 on September 21, 2016
Recall Number Z-0372-2016
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, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate
Code Information Batch # 14KT47574
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 2		 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.
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