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U.S. Department of Health and Human Services

Class 2 Device Recall PERILOC VOLAR DISTAL RADIUS RIGHT 3H STD HEAD LOCKING PLATE

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  Class 2 Device Recall PERILOC VOLAR DISTAL RADIUS RIGHT 3H STD HEAD LOCKING PLATE see related information
Date Initiated by Firm March 22, 2017
Date Posted April 14, 2017
Recall Status1 Terminated 3 on June 03, 2022
Recall Number Z-2036-2017
Recall Event ID 76934
510(K)Number K092015  
Product Classification Plate, fixation, bone - Product Code HRS
Product PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116
Code Information Lot 16DM15958
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
Manufacturer Reason
for Recall		 This lot of left plates were laser etched and packaged as right plates.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Smith & Nephew initiated their recall by email on March 22, 2017. Consignees are being requested to return all affected product in their possession. Distributors were instructed to notify their customers and ensure that the recall instructions were followed. For further questions, please call : 1(800) 821-5700.
Quantity in Commerce 12 units
Distribution Internationally to the country of : India
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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