Reported Jun 13, 2018 · Terminated
Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010)…
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?
- Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label
- Size (Part Number)a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (002-D-32012) c) D 3.2MM X 14MM (002-D-32014) d) D 3.2MM X 16MM (002-D-32016) e) D 3.2MM X 18MM (002-D-32018) f) D 3.2MM X 20MM (002-D-32020) g) D 3.2MM X 22MM (002-D-32022) h) D 3.2MM X 24MM (002-D-32024) i) D 3.2MM X 26MM (002-D-32026) j) D 3.2MM X 28MM (002-D-32028) k) D 3.2MM X 30MM (002-D-32030) l) D 3.2MM X 32MM (002-D-32032) m) D 3.2MM X 34MM (002-D-32034) n) D 3.2MM X 36MM (002-D-32036) o) D 3.2MM X 38MM (002-D-32038) p) D 3.2MM X 40MM (002-D-32040) q) D 3.2MM X 42MM (002-D-32042) r) D 3.2MM X 44MM (002-D-32044) s) D 3.2MM X 46MM (002-D-32046) t) D 3.2MM X 48MM (002-D-32048) u) D 3.2MM X 50MM (002-D-32050)
- Lot codes and dates
20 of 20 products
Products covered by this recall # Barcodes Product as published 1 18056099645959(18056099645959) B1082246 2 18056099645966(18056099645966) B1075836 3 18056099645973(18056099645973) B1084806 4 18056099645980(18056099645980) B1089892 5 18056099645997(18056099645997) B1075845 6 18056099646000(18056099646000) B1084797 7 18056099646017(18056099646017) B1084792 8 18056099646024(18056099646024) B1084799 9 18056099646031(18056099646031) B1083858 10 18056099646048(18056099646048) B1083859 11 18056099646055(18056099646055) B1089891, B1195735 12 1805609964606218056099646079(18056099646062) B1195736, B1089882; m)(18056099646079) B1204992, B1083850 13 18056099646086(18056099646086) B1083848, B1195699 14 18056099646093(18056099646093) B1195732, B1089896 15 18056099646109(18056099646109) B1204991, B1083642 16 18056099646116(18056099646116) B1195739, B1083851 17 18056099646123(18056099646123) B1204988, B1083637 18 18056099646130(18056099646130) B1195733, B1089898 19 18056099646147(18056099646147) B1195744, B1083838 20 18056099646154(18056099646154) B1195730, B1071599, B1083853 - Amount recalled
- 1206
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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