VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM recallZ-2128-2018 · 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-2128-2018
- Status
- Terminated
- Initiated by the company
- Apr 6, 2018
- Posted by the FDA
- Jun 7, 2018
- Recalling firm
- Orthofix, Inc
- Quantity
- 75
- Product code
- HRS
- FDA submissions
- K142135
- 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
H-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 Spacer (003-H-25001); 30 MM (003-H-30001)
Code information (models, lots, serial numbers)
Lot: B1212400, Date of Manufacture: 2017-11-13, Use By: 2022-10-13, (UDI)/Lot: a) (18056099647908) B1096740; b) (18056099647915) B1096733; c) (18056099647939) B1096734; d) (18056099647953) B1096735; e) (18056099647960) B1100226
Devices named in this recall
5 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 · Plate, 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 · Plate, Fixation, Bone1 recall0 reports
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM 1Orthofix Srl · Plate, Fixation, Bone1 recall0 reports
Product lines
Other devices under the same FDA submission
5 devices cleared under K142135 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 · Plate, 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 · Plate, 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 · 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-2127-2018 · TerminatedEvans 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-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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