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Class 2 Device Recall LPlate |
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Date Initiated by Firm |
April 06, 2018 |
Date Posted |
June 07, 2018 |
Recall Status1 |
Terminated 3 on June 30, 2021 |
Recall Number |
Z-2130-2018 |
Recall Event ID |
79819 |
510(K)Number |
K140876
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Product Classification |
Plate, fixation, bone - Product Code HRS
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Product |
L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R) |
Code Information |
(UDI)/Lot: a) (18056099647830) B1108952; b) (18056099647847) B1108955 |
Recalling Firm/ Manufacturer |
Orthofix, Inc 3451 Plano Pkwy Lewisville TX 75056-9453
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For Additional Information Contact |
Gianluca Ricadona 469-742-2500
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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.
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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 |
30 |
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
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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.
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510(K) Database |
510(K)s with Product Code = HRS and Original Applicant = ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC
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