Reported Jun 13, 2018 · Terminated
Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM…
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?
8 of 8 products
| # | Product as published |
|---|---|
| 1 | Small/0MM Step/Left (002-C-01000L) |
| 2 | Small/0MM Step/Right (002-C-01000R) |
| 3 | Large/0MM Step/Left (002-C-02000L) |
| 4 | Large/0MM Step/Right (002-C-02000R) |
| 5 | Small/2MM Step/Left (002-C-01002L) |
| 6 | Small/2MM Step/Right (002-C-01002R) |
| 7 | Large/2MM Step/Left (002-C-02002L) |
| 8 | Large/2MM Step/Right (002-C-02002R) |
- Lot codes and dates
8 of 8 products
Products covered by this recall # Barcodes Product as published 1 18056099647588(18056099647588) B1096741 2 18056099647595(18056099647595) B1117260, B1099064 3 18056099647625(18056099647625) B1117352, B1096743 4 18056099647632(18056099647632) B1099065 5 18056099647601(18056099647601) B1117265 6 18056099647618(18056099647618) B1098803, B1116361 7 1805609964764918056099647649) B1200565, B1116364 8 18056099647656(18056099647656) B1123046 - Amount recalled
- 156
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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