Z-2127-2018Class II

Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer...

Name: Z-2127-2018 Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer...
Creator: Orthofix, Inc
Published: 2018-04-06
License: https://open.fda.gov/license/

Orthofix SRL / initiated 2018-04-06 / Terminated / root cause: design

FDA source

Orthofix, Inc began a recall of 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... on 2018-04-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2127-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-06
Posted: 2018-06-07
Terminated: 2021-06-30
Recalling firm: Orthofix SRL
Product: 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) 12MM Spacer (002-H-00012)
Product code: HRS Plate, Fixation, Bone
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.
Root cause tag: design
FDA root cause: 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: 52
Distribution: U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
Product codes and lots: Lot: B1212604, Date of Manufacture: 2017-11-15, Use By: 2022-10-15, UDI: a) (18056099647724) B1099059, B1123627; b) (18056099647731) B1099057; c) (18056099647748) B1099068; d (18056099647755) B1099069

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2127-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2116-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2117-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2118-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2119-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2120-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2121-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2122-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2123-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2124-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2125-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2126-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2127-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2128-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2129-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2130-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2131-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2132-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2133-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2134-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07
Z-2135-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-13	2018-06-07

Product code HRS

K140876Class IIView Plating System,reduce Fracture Plating System,bone ScrewIcon Orthopedic Concepts, LLC Dba Edge Orthopaedic / cleared 2014-07-22

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)