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U.S. Department of Health and Human Services

Class 2 Device Recall TN Plate

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 Class 2 Device Recall TN Platesee related information
Date Initiated by FirmApril 06, 2018
Date PostedJune 07, 2018
Recall Status1 Terminated 3 on June 30, 2021
Recall NumberZ-2133-2018
Recall Event ID 79819
510(K)NumberK140876 
Product Classification Plate, fixation, bone - Product Code HRS
ProductTN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025); c) Large (002-F-01030)
Code Information (UDI)/Lot: a) (18056099647663) B1099060; b) (18056099647670) B1099062; c) (18056099647687) B1099066
Recalling Firm/
Manufacturer
Orthofix, Inc
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information ContactGianluca 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
ActionOn 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 Commerce24
DistributionU.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HRS
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