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U.S. Department of Health and Human Services

Class 2 Device Recall NonLocking Screw

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  Class 2 Device Recall NonLocking 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-2121-2018
Recall Event ID 79819
510(K)Number K140876  
Product Classification Plate, fixation, bone - Product Code HRS
Product Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008);
b) D 2.7MM X 10MM (002-D-27010);
c) D 2.7MM X 12MM (002-D-27012);
d) D 2.7MM X 14MM (002-D-27014);
e) D 2.7MM X 16MM (002-D-27016);
f) D 2.7MM X 18MM (002-D-27018);
g) D 2.7MM X 20MM (002-D-27020);
h) D 2.7MM X 22MM (002-D-27022);
i) D 2.7MM X 24MM (002-D-27024);
j) D 2.7MM X 26MM (002-D-27026);
k) D 2.7MM X 28MM (002-D-27028);
l) D 2.7MM X 30MM (002-D-27030);
m) D 2.7MM X 32MM (002-D-27032);
n) D 2.7MM X 34MM (002-D-27034);
o) D 2.7MM X 36MM (002-D-27036);
p) D 2.7MM X 38MM (002-D-27038);
q) D 2.7MM X 40MM (002-D-27040)
Code Information (UDI)/Lot: a) (8056099645782) B1075108; b) (18056099645799) B1075105 c) (18056099645805) B1071598, B1075178, B1075178; d) 18056099645812) B1069675, B1075431, B1075431; e) (18056099645829) B1071545, B1075435; f) (18056099645836) B1071540, B1075839; g) (18056099645843) B1068567, B1075827, B1075827; h) (18056099645850) B1082175, B1082175; i) (18056099645867) B1082237, B1068549, B1082237; j) (18056099645874) B1075060, B1082182; k) (18056099645881) B1068574, B1082236; l) (18056099645898) B1204990, B1071594, B1082232; m) (18056099645904) B1204993, B1071543, B1082222; n) (18056099645911) B1071542, B1195742, B1083645; o) (18056099645928) B1071539, B1083644, B1195708, B1083644; p) (18056099645935) B1204989, B1071541, B1089895; q) (18056099645942) B1069679, B1195752, B1069679, B1082235
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 935
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