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U.S. Department of Health and Human Services

Class 2 Device Recall Locking Screw

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  Class 2 Device Recall Locking 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-2124-2018
Recall Event ID 79819
510(K)Number K140876  
Product Classification Plate, fixation, bone - Product Code HRS
Product Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010)
b) D 3.2MM X 12MM (002-E-32012)
c) D 3.2MM X 14MM (002-E-32014)
d) D 3.2MM X 16MM (002-E-32016)
e) D 3.2MM X 18MM (002-E-32018)
f) D 3.2MM X 20MM (002-E-32020)
g) D 3.2MM X 22MM (002-E-32022)
h) D 3.2MM X 24MM (002-E-32024)
i) D 3.2MM X 26MM (002-E-32026)
j) D 3.2MM X 28MM (002-E-32028)
k) D 3.2MM X 30MM (002-E-32030)
l) D 3.2MM X 32MM (002-E-32032)
m) D 3.2MM X 34MM (002-E-32034)
n) D 3.2MM X 36MM (002-E-32036)
o) D 3.2MM X 38MM (002-E-32038)
p) D 3.2MM X 40MM (002-E-32040)
q) D 3.2MM X 42MM (002-E-32042)
r) D 3.2MM X 44MM (002-E-32044)
s) D 3.2MM X 46MM (002-E-32046)
t) D 3.2MM X 48MM (002-E-32048)
u) D 3.2MM X 50MM (002-E-32050)
Code Information (UDI)/Lot: a) (18056099646505) B1075433; b) (18056099646512) B1075434; c) (18056099646529) B1075844; d) (18056099646536) B1075432; e) (18056099646543) B1075436; f) (18056099646550) B1075826; g) (18056099646567) B1075837; h) (18056099646574) B1084804; i) (18056099646581) B1075835; j) (18056099646598) B1082233; k) (18056099646604) B1204272, B1075829; l) (18056099646611) B1204977, B1082245; m) (18056099646628) B1215471, B1204978, B1082247; n) (18056099646635) B1204979, B1084800; o) (18056099646642) B1204582, B1082248; p) (18056099646659) B1218842, B1204980; q) (18056099646666) B1218840, B1204271, B1089889; r) (18056099646673) B1218843, B1195750, B1083640; s) (18056099646680) B1204981, B1083837; t) (18056099646697) B1204982, B1083846; u) (18056099646703) B1204584, B1083852, B1071600, B1071601 
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 1574
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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