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U.S. Department of Health and Human Services

Class 2 Device Recall MicroPort Orthopedics SCHANZ SCREW SELF DRILL

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  Class 2 Device Recall MicroPort Orthopedics SCHANZ SCREW SELF DRILL see related information
Date Initiated by Firm September 18, 2017
Create Date October 11, 2018
Recall Status1 Terminated 3 on April 08, 2021
Recall Number Z-0043-2018
Recall Event ID 78150
510(K)Number K952296  
Product Classification Screw, fixation, bone - Product Code HWC
Product MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R

Product Usage:
MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed
Code Information lot 1723305
Recalling Firm/
Manufacturer		 MicroPort Orthopedics Inc.
5677 Airline Rd
Arlington TN 38002-9501
Manufacturer Reason
for Recall		 The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the products sterility assurance and may lead to serious adverse events such as infections, both localized and systemic.
FDA Determined
Cause 2		 Packaging process control
Action Microport initiated their recall by letter sent via email on 09/18/2017. The letter identified the affected product, problem and actions to be taken. The consignees were directed to check their stock, including all kits and consignment stock to immediately determine if any affected product was in stock. The firm requested return of the recalled units. Consignees with questions regarding the return of the product were directed MPOs Customer Experience Department available Monday through Friday 7:30 am to 7:30 pm CST, at 1-866-872-0211.
Quantity in Commerce 48 units
Distribution Worldwide Distribution - US Nationwide in the states of TX, AL, AZ CO, KS ,ME MO, WB, LA, CA, MD, including PR and the country of CANADA
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 = SYNTHES (USA)
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