Reported Jun 13, 2018 · Terminated
Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008), 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?
17 of 17 products
| # | Product as published |
|---|---|
| 1 | D 2.7MM X 8MM (002-E-27008) |
| 2 | D 2.7MM X 10MM (002-E-27010) |
| 3 | D 2.7MM X 12MM (002-E-27012) |
| 4 | D 2.7MM X 14MM (002-E-27014) |
| 5 | D 2.7MM X 16MM (002-E-27016) |
| 6 | D 2.7MM X 18MM (002-E-27018) |
| 7 | D 2.7MM X 20MM (002-E-27020) |
| 8 | D 2.7MM X 22MM (002-E-27022) |
| 9 | D 2.7MM X 24MM (002-E-27024) |
| 10 | D 2.7MM X 26MM (002-E-27026) |
| 11 | D 2.7MM X 28MM (002-E-27028) |
| 12 | D 2.7MM X 30MM (002-E-27030) |
| 13 | D 2.7MM X 32MM (002-E-27032) |
| 14 | D 2.7MM X 34MM (002-E-27034) |
| 15 | D 2.7MM X 36MM (002-E-27036) |
| 16 | D 2.7MM X 38MM (002-E-27038) |
| 17 | D 2.7MM X 40MM (002-E-27040) |
- Lot codes and dates
17 of 17 products
Products covered by this recall # Barcodes Product as published 1 18056099646338(18056099646338) B1075104 2 18056099646345(18056099646345) B1071537, B1083847 3 18056099646352(18056099646352) B1068544, B1075103 4 18056099646369(18056099646369) B1075176 5 18056099646376(18056099646376) B1075838 6 18056099646383(18056099646383) B1069676, B1082189 7 18056099646390(18056099646390) B1071602, B1082231 8 18056099646406(18056099646406) B1069678, B1084787 9 18056099646413(18056099646413) B1071672, B1082227, B1071672, B1075052 10 18056099646420(18056099646420) B1082238 11 18056099646437(18056099646437) B1084801 12 18056099646444(18056099646444) B1082214, B1204276 13 18056099646451(18056099646451) B1215467, B1089836 14 18056099646468(18056099646468) B1215470, B1089877 15 18056099646475(18056099646475) B1215466, B1089894 16 18056099646482(18056099646482) B1195749, B1082234 17 18056099646499(18056099646499) B1204583, B1089842 - Amount recalled
- 1302
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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