Reported Jun 13, 2018 · Terminated
H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spacer (003-H-12001); b) 15MM…
Orthofix, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthofix, Inc · 3451 Plano Pkwy · Lewisville, TX · 75056-9453
Is this the product you have?
- 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)
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 18056099647908(18056099647908) B1096740 2 18056099647915(18056099647915) B1096733 3 18056099647939(18056099647939) B1096734 4 18056099647953(18056099647953) B1096735 5 18056099647960(18056099647960) B1100226 - Amount recalled
- 75
This recall covers 20 products
The agency filed one notice per product. You are reading one of them; the other 19 are below.
7 more are in the archive.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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