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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-2122-2018
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 2.7MM X 8MM (002-E-27008),
b) D 2.7MM X 10MM (002-E-27010);
c) D 2.7MM X 12MM (002-E-27012);
d) D 2.7MM X 14MM (002-E-27014);
e) D 2.7MM X 16MM (002-E-27016);
f) D 2.7MM X 18MM (002-E-27018);
g) D 2.7MM X 20MM (002-E-27020);
h) D 2.7MM X 22MM (002-E-27022);
i) D 2.7MM X 24MM (002-E-27024);
j) D 2.7MM X 26MM (002-E-27026);
k) D 2.7MM X 28MM (002-E-27028);
l) D 2.7MM X 30MM (002-E-27030);
m) D 2.7MM X 32MM (002-E-27032);
n) D 2.7MM X 34MM (002-E-27034);
o) D 2.7MM X 36MM (002-E-27036);
p) D 2.7MM X 38MM (002-E-27038);
q) D 2.7MM X 40MM (002-E-27040)
Code Information (UDI)/Lot: a) (18056099646338) B1075104; b) (18056099646345) B1071537, B1083847; c) (18056099646352) B1068544, B1075103; d) (18056099646369) B1075176; e) (18056099646376) B1075838; f) (18056099646383) B1069676, B1082189; g) (18056099646390) B1071602, B1082231; h) (18056099646406) B1069678, B1084787; i) (18056099646413) B1071672, B1082227, B1071672, B1075052; j) (18056099646420) B1082238; k) (18056099646437) B1084801; l) (18056099646444) B1082214, B1204276; m) (18056099646451) B1215467, B1089836; n) (18056099646468) B1215470, B1089877; o) (18056099646475) B1215466, B1089894; p) (18056099646482) B1195749, B1082234; q) (18056099646499) B1204583, B1089842
Recalling Firm/
Orthofix, Inc
3451 Plano Pkwy
Lewisville TX 75056-9453
For Additional Information Contact Gianluca Ricadona
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 1302
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