VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1 (REF 002-E-27018)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 18056099646383), received between Jan 23, 2018 and Jan 23, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

1 FDA recall record name this device's identifier.

14 other recalls cover devices cleared under the same FDA submission (K140876); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Apr 6, 2018Terminated

   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.

   Z-2122-2018 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2018Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY THE LOCAL DISTRIBUTOR INDICATES: HOSPITAL NAME: (B)(6); SURGEON NAME: (B)(6); DATE OF SURGERY: (B)(6) 2017; BODY PART TO WHICH DEVICE WAS APPLIED: FOOT; SURGERY DESCRIPTION: NO RESPONSE; PATIENT INFORMATION: (B)(6), MALE; PROBLEM OBSERVED DURING: CLINICAL USE ON PATIENT; TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: SCREWS FAILED DURING SURGERY, (B)(4) THREADS STRIPPED DURING INSERTION BUT WAS ABLE TO REMOVE (PLEASE KINDLY REFER TO MFR REPORT 9680825-2018-0002). (B)(4), ONE THREADS STRIPPED DURING INSERTION AND THE OTHER HEAD BROKE OFF AT THE NECK DURING INSERTION (PLEASE KINDLY REFER TO MFR REPORTS 9680825-2018-00003 AND 9680825-2018-00004). THEY REMAIN IN PATIENT. THE COMPLAINT REPORT FORM ALSO INDICATES: THE DEVICE FAILURE DID NOT HAVE ANY ADVERSE EFFECTS ON PATIENT; THE SURGERY WAS NOT COMPLETED WITH THE DEVICE; A REPLACEMENT DEVICE WAS IMMEDIATELY AVAILABLE TO COMPLETE THE SURGERY; THE EVENT DID NOT LEAD TO A CLINICALLY RELEVANT INCREASE IN THE DURATION OF THE SURGICAL PROCEDURE (10 MINUTES); AN ADDITIONAL SURGERY WAS NOT REQUIRED; COPIES OF THE OPERATIVE REPORT ARE AVAILABLE (NOT RECEIVED); COPIES OF THE X-RAY IMAGES ARE AVAILABLE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7211653 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140876. One submission often covers many models, so check the product and lot details in each record.

• Z-2124-2018 · Apr 6, 2018 · Terminated
  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)
• Z-2127-2018 · Apr 6, 2018 · Terminated
  Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006); b) 8MM Spacer (022-H-00008); c) 10MM Spacer (002-H-00010); d) 12M
• Z-2123-2018 · Apr 6, 2018 · Terminated
  Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (002-D-32012) c) D 3.2MM X 14MM (002-D-320
• Z-2131-2018 · Apr 6, 2018 · Terminated
  MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002); c) Large (002-B-03003)
• Z-2135-2018 · Apr 6, 2018 · Terminated
  Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
• Z-2119-2018 · Apr 6, 2018 · Terminated
  Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010); c) D 2.0MM X 12MM (002-D
• Z-2133-2018 · Apr 6, 2018 · Terminated
  TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025); c) Large (002-F-01030)
• Z-2126-2018 · Apr 6, 2018 · Terminated
  CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020); b) Medium (002-G-01025); c) Large (002-G-01030)
• Z-2120-2018 · Apr 6, 2018 · Terminated
  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 1
• Z-2132-2018 · Apr 6, 2018 · Terminated
  Straight 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)
• Z-2130-2018 · Apr 6, 2018 · Terminated
  L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R)
• Z-2134-2018 · Apr 6, 2018 · Terminated
  T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001)
• Z-2121-2018 · Apr 6, 2018 · Terminated
  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 2.7
• Z-2129-2018 · Apr 6, 2018 · Terminated
  Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-01000L); b) Small/0MM Step/Right (002-C-0100