• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Straight Plate

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Straight Platesee related information
Date Initiated by FirmApril 06, 2018
Date PostedJune 07, 2018
Recall Status1 Terminated 3 on June 30, 2021
Recall NumberZ-2132-2018
Recall Event ID 79819
510(K)NumberK140876 
Product Classification Plate, fixation, bone - Product Code HRS
ProductStraight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001)
Code Information (UDI)/Lot: a) (18056099647809) B1096736; b) (18056099647816) B1096738; c) (18056099647823) B1096739
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 Commerce38
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
-
-