Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Locking Screw

  • 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 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-2120-2018
Recall Event ID 79819
510(K)Number K140876  
Product Classification Plate, fixation, bone - Product Code HRS
Product Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010);
c) D 2.0MM X 12MM (002-E-20012);
d) D 2.0MM X 14MM (002-E-20014);
e) D 2.0MM X 16MM (002-E-20016);
f) D 2.0MM X 18MM (002-E-20018);
g) D 2.0MM X 20MM (002-E-20020);
h) D 2.0MM X 22MM (002-E-20022);
i) D 2.0MM X 24MM (002-E-20024);
j) D 2.0MM X 26MM (002-E-20026);
k) D 2.0MM X 28MM (002-E-20028);
l) D 2.0MM X 30MM (002-E-20030)
Code Information (UDI)/Lot: a) (18056099646161)B1204974, B1089899, B1201171, B1201171;  b) (18056099646178) B1195696, B1204268, B1083839;  c) (18056099646185) B1215486, B1201172, B1201172, B1204281, B1083845;  d) (18056099646192) B1215489, B1204975, B1083855, B1201173, B1201173;  e) (18056099646208) B1215482, B1204585, B1195748, B1089887;  f) (18056099646215) B1215488, B1204559, B1083856;  g) (18056099646222) B1215483, B1204558, B1083854;  h) (18056099646239) B1215490, B1204277, B1195721, B1083849;  i) (18056099646246) B1215484, B1204279, B1195703, B1089890;  j) (18056099646253) B1215491, B1204283, B1195720, B1083648;  k) (18056099646260) B1215485, B1089879, B1201174, B1204267, B1204267;  l) (18056099646277) B1215487, B1204284, B1195751, B1083857  
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 870
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
-
-