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U.S. Department of Health and Human Services

Class 2 Device Recall HPlate

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  Class 2 Device Recall HPlate 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-2128-2018
Recall Event ID 79819
510(K)Number K142135  
Product Classification Plate, fixation, bone - Product Code HRS
Product H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number):
a) 12MM Spacer (003-H-12001);
b) 15MM Spacer (003-H-15001);
20MM Spacer (003-H-20001);
25MM Spacer (003-H-25001);
30 MM (003-H-30001)
Code Information Lot: B1212400, Date of Manufacture: 2017-11-13, Use By: 2022-10-13, (UDI)/Lot:  a) (18056099647908) B1096740; b) (18056099647915) B1096733; c) (18056099647939) B1096734; d) (18056099647953) B1096735; e) (18056099647960) B1100226
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 75
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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