VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM recallZ-2127-2018 · Orthofix, Inc · initiated Apr 6, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Orthofix, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2127-2018
- Status
- Terminated
- Initiated by the company
- Apr 6, 2018
- Posted by the FDA
- Jun 7, 2018
- Recalling firm
- Orthofix, Inc
- Quantity
- 52
- Product code
- HRS
- FDA submissions
- K140876
- Distribution
- U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
Product description
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)
Code information (models, lots, serial numbers)
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
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Screw, Fixation, Bone1 recall0 reports
Product lines
Other devices under the same FDA submission
125 devices cleared under K140876 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Screw, Fixation, Bone1 recall2 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Screw, Fixation, Bone1 recall2 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Plate, Fixation, Bone1 recall1 report
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Screw, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Plate, Fixation, Bone1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 79819).
- Z-2116-2018 · TerminatedRival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C
- Z-2117-2018 · TerminatedRival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C
- Z-2118-2018 · TerminatedRival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C
- Z-2119-2018 · TerminatedNon-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-2120-2018 · TerminatedLocking 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-2121-2018 · TerminatedNon-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-2122-2018 · TerminatedLocking 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…
- Z-2123-2018 · TerminatedNon-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-2124-2018 · TerminatedLocking 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-2125-2018 · TerminatedBox Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001); b) 22MM (003-F-22001); c) 30MM (003-F-30001)
- Z-2126-2018 · TerminatedCC 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-2128-2018 · TerminatedH-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spacer (003-H-12001); b) 15MM Spacer (003-H-15001); 20MM Spacer (003-H-20001); 25MM Spac…
- Z-2129-2018 · TerminatedLapidus 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…
- Z-2130-2018 · TerminatedL-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-2131-2018 · TerminatedMTP 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-2132-2018 · TerminatedStraight 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-2133-2018 · TerminatedTN 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-2134-2018 · TerminatedT-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-2135-2018 · TerminatedY-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001)
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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