Reported Jun 13, 2018 · Terminated
Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM…
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?
12 of 12 products
| # | Product as published |
|---|---|
| 1 | D 2.0MM X 8MM (0002-D-20008) |
| 2 | D 2.0MM X 10MM (002-D-20010) |
| 3 | D 2.0MM X 12MM (002-D-20012) |
| 4 | D 2.0MM X 14MM (002-D-20014) |
| 5 | D 2.0MM X 16MM (002-D-20016) |
| 6 | D 2.0MM X 18MM (002-D-20018) |
| 7 | D 2.0MM X 20MM (002-D-20020) |
| 8 | D 2.0MM X 22MM (002-D-20022) |
| 9 | D 2.0MM X 24MM (002-D-20024) |
| 10 | D 2.0MM X 26MM (002-D-20026) |
| 11 | D 2.0MM X 28MM (002-D-20028) |
| 12 | D 2.0MM X 30MM (002-D-20030) |
- Lot codes and dates
12 of 12 products
Products covered by this recall # Barcodes Product as published 1 18056099645614(18056099645614) B1204542, B1101808 2 18056099645621(18056099645621) B1204969, B1201169, B1075101 3 18056099645638(18056099645638) B1204554, B1195701, B1075428 4 18056099645645(18056099645645) B1204971, B1201176, B1075846 5 18056099645652(18056099645652) B1195727, B1204266, B1075426 6 18056099645669(18056099645669) B1204540, B1075429 7 18056099645676(18056099645676) B1204541, B1075425 8 18056099645683(18056099645683) B1204539, B1075177 9 18056099645690(18056099645690) B1204972, B1195700, B1075847 10 18056099645706(18056099645706) B1204555, B1195702, B1075427 11 18056099645713(18056099645713) B1204973, B1201170, B1075430 12 18056099645720(18056099645720) B1075825, B1201166, B1204270 - Amount recalled
- 601
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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