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U.S. Department of Health and Human Services

Class 2 Device Recall PeriLoc(R) VLP 3.5 MM X 6 MM SELFTAPPING CORTEX SCREW

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  Class 2 Device Recall PeriLoc(R) VLP 3.5 MM X 6 MM SELFTAPPING CORTEX SCREW see related information
Date Initiated by Firm March 09, 2017
Create Date April 18, 2017
Recall Status1 Terminated 3 on August 21, 2019
Recall Number Z-1854-2017
Recall Event ID 76729
510(K)Number K062216  
Product Classification Plate, fixation, bone - Product Code HRS
Product Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306
Orthopedic
Code Information Batch 15HM05197
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact David M. Snyder
978-749-1440
Manufacturer Reason
for Recall		 The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
FDA Determined
Cause 2		 Labeling Change Control
Action Smith & Nephew sent an Urgent Medical First Recall Notice dated March 9, 2017, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested the quarantine and return of the devices, and for the distributors to notify their consignees and ensure the same actions. International consignees were notified by email. Consignees with questions were instructed to contact FieldAction@smith-nephew.com. For questions regarding this recall call 978-749-1440.
Quantity in Commerce 1 unit
Distribution Worldwide Distribution - US (Nationwide) Internationally to Colombia, Denmark, Finland, France, Great Britain, Italy, and Singapore
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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