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U.S. Department of Health and Human Services

Class 2 Device Recall NonLocking Screw

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  Class 2 Device Recall NonLocking Screw see related information
Date Initiated by Firm April 06, 2018
Date Posted June 07, 2018
Recall Status1 Terminated 3 on June 30, 2021
Recall Number Z-2119-2018
Recall Event ID 79819
510(K)Number K140876  
Product Classification Plate, fixation, bone - Product Code HRS
Product Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010);
c) D 2.0MM X 12MM (002-D-20012);
d) D 2.0MM X 14MM (002-D-20014);
e) D 2.0MM X 16MM (002-D-20016);
f) D 2.0MM X 18MM (002-D-20018);
g) D 2.0MM X 20MM (002-D-20020);
h) D 2.0MM X 22MM (002-D-20022);
i) D 2.0MM X 24MM (002-D-20024);
j) D 2.0MM X 26MM (002-D-20026);
k) D 2.0MM X 28MM (002-D-20028);
l) D 2.0MM X 30MM (002-D-20030)
Code Information (UDI)/Lot: a) (18056099645614) B1204542, B1101808;  b) (18056099645621) B1204969, B1201169, B1075101;  c) (18056099645638) B1204554, B1195701, B1075428;  d) (18056099645645) B1204971, B1201176, B1075846;  e) (18056099645652) B1195727, B1204266, B1075426;  f) (18056099645669) B1204540, B1075429;  g) (18056099645676) B1204541, B1075425;  h) (18056099645683) B1204539, B1075177;  i) (18056099645690) B1204972, B1195700, B1075847;  j) (18056099645706) B1204555, B1195702, B1075427;  k) (18056099645713) B1204973, B1201170, B1075430;  l) (18056099645720) B1075825, B1201166, B1204270   
Recalling Firm/
Manufacturer		 Orthofix, Inc
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information Contact Gianluca Ricadona
469-742-2500
Manufacturer Reason
for Recall		 Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. As the result of a complaint investigation, the locking screws were confirmed to not properly engage the plates during surgery.
FDA Determined
Cause 2		 Device Design
Action On 04/06/2018, Orthofix Inc. (U.S. Agent), sent written notification of the recall to distributors and hospitals via e-mail and/or FedEx overnight courier.
Quantity in Commerce 601
Distribution U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
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 = ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC
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