Reported Jun 13, 2018 · Terminated
Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b)…
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?
21 of 21 products
| # | Product as published |
|---|---|
| 1 | D 3.2MM X 10MM (002-E-32010) |
| 2 | D 3.2MM X 12MM (002-E-32012) |
| 3 | D 3.2MM X 14MM (002-E-32014) |
| 4 | D 3.2MM X 16MM (002-E-32016) |
| 5 | D 3.2MM X 18MM (002-E-32018) |
| 6 | D 3.2MM X 20MM (002-E-32020) |
| 7 | D 3.2MM X 22MM (002-E-32022) |
| 8 | D 3.2MM X 24MM (002-E-32024) |
| 9 | D 3.2MM X 26MM (002-E-32026) |
| 10 | D 3.2MM X 28MM (002-E-32028) |
| 11 | D 3.2MM X 30MM (002-E-32030) |
| 12 | D 3.2MM X 32MM (002-E-32032) |
| 13 | D 3.2MM X 34MM (002-E-32034) |
| 14 | D 3.2MM X 36MM (002-E-32036) |
| 15 | D 3.2MM X 38MM (002-E-32038) |
| 16 | D 3.2MM X 40MM (002-E-32040) |
| 17 | D 3.2MM X 42MM (002-E-32042) |
| 18 | D 3.2MM X 44MM (002-E-32044) |
| 19 | D 3.2MM X 46MM (002-E-32046) |
| 20 | D 3.2MM X 48MM (002-E-32048) |
- Lot codes and dates
21 of 21 products
Products covered by this recall # Barcodes Product as published 1 18056099646505(18056099646505) B1075433 2 18056099646512(18056099646512) B1075434 3 18056099646529(18056099646529) B1075844 4 18056099646536(18056099646536) B1075432 5 18056099646543(18056099646543) B1075436 6 18056099646550(18056099646550) B1075826 7 18056099646567(18056099646567) B1075837 8 18056099646574(18056099646574) B1084804 9 18056099646581(18056099646581) B1075835 10 18056099646598(18056099646598) B1082233 11 18056099646604(18056099646604) B1204272, B1075829 12 18056099646611(18056099646611) B1204977, B1082245 13 18056099646628(18056099646628) B1215471, B1204978, B1082247 14 18056099646635(18056099646635) B1204979, B1084800 15 18056099646642(18056099646642) B1204582, B1082248 16 18056099646659(18056099646659) B1218842, B1204980 17 18056099646666(18056099646666) B1218840, B1204271, B1089889 18 18056099646673(18056099646673) B1218843, B1195750, B1083640 19 18056099646680(18056099646680) B1204981, B1083837 20 18056099646697(18056099646697) B1204982, B1083846 - Amount recalled
- 1574
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.
Want the full recall guide?
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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