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U.S. Department of Health and Human Services

Class 2 Device Recall CLAW(R) II 2 HOLE PLATE ORTHOLOC(TM) 3DSi, LENGTH 25mm

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  Class 2 Device Recall CLAW(R) II 2 HOLE PLATE ORTHOLOC(TM) 3DSi, LENGTH 25mm see related information
Date Initiated by Firm July 30, 2014
Date Posted September 08, 2014
Recall Status1 Terminated 3 on June 15, 2018
Recall Number Z-2603-2014
Recall Event ID 69058
510(K)Number K080295  K133715  K113014  
Product Classification Plate, fixation, bone - Product Code HRS
Product CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE

Orthopedic
Code Information Lot Numbers: 1490367, 1490368, 1512152, 1521232, 1523734, 1523746, 1537160, 1537161, 1539401, 1541613, 1541614, 1542652, 1542774, 1542775
Recalling Firm/
Manufacturer		 Wright Medical Technology, Inc.
1023 Cherry Rd
Memphis TN 38117-5423
For Additional Information Contact Julie Tracy
800-238-7117
Manufacturer Reason
for Recall		 Plates manufactured from an incorrect raw material.
FDA Determined
Cause 2		 Device Design
Action Wright Medical sent an Urgent Medical Device Recall letter dated July 25, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product and immediately quarantine all affected product and return to Wright Medical as soon as possible. For return instructions customers were instructed to contact Customer Service at 800-238-7117. Customers were also asked to complete the attached response form, confirming receipt of the notice and the status of the product(s) on hand and return by fax to 901-867-7401. Customers with questions were instructed to call 901-290-5662. For questions regarding this recall call 800-238-7117.
Quantity in Commerce 400 units
Distribution Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.
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 = WRIGHT MEDICAL TECHNOLOGY, INC.
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