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U.S. Department of Health and Human Services

Class 2 Device Recall Integra

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  Class 2 Device Recall Integra see related information
Date Initiated by Firm July 21, 2016
Create Date August 19, 2016
Recall Status1 Terminated 3 on March 29, 2017
Recall Number Z-2600-2016
Recall Event ID 74855
510(K)Number K071639  
Product Classification Screw, fixation, bone - Product Code HWC
Product Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only,

Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.
Code Information Model Numbers: 121530S, 121535S, 121540S, 121545S, 121550S, 121555S, 121560S, 121565S, 121570S, 121575S, 121580S, 121740S, 121745S, 121750S, 121755S, 121760S, 121765S, 121770S, 121775S, 121780S, 121785S, 121790S, 121795S, 121800S, 121805S, 121810S, 121815S and 121820S
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Dr. Patricia Kihn
609-275-0500
Manufacturer Reason
for Recall		 Labeling on the Qwix Screw product states that it is a "compression screw" instead of a "positioning screw".
FDA Determined
Cause 2		 Labeling mix-ups
Action Integra sent an Urgent Voluntary Medical Device Recall letter and acknowledgement return response form dated July 21, 2016 to their affected customers. The recall letter identifies the product and lots involved, problem and actions to be taken. All customers are asked to return the completed acknowledgement and return response form by email to FCA1@integralife.com or fax to 1-609-275-9445. Should any customer has any questions regarding the instructions, they can contact Customer Service at 1-800-654-2873.
Quantity in Commerce 120 units from multiple lots
Distribution US Nationwide Distribution in the states of AL, GA, ID, MA, MD, MN, NC, NJ, NY, OH, OK, PA, PR, TX, VA and WA
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 = HWC and Original Applicant = NEWDEAL SAS
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