Reported Jun 13, 2018 · Terminated
Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X…
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-D-27008) |
| 2 | D 2.7MM X 10MM (002-D-27010) |
| 3 | D 2.7MM X 12MM (002-D-27012) |
| 4 | D 2.7MM X 14MM (002-D-27014) |
| 5 | D 2.7MM X 16MM (002-D-27016) |
| 6 | D 2.7MM X 18MM (002-D-27018) |
| 7 | D 2.7MM X 20MM (002-D-27020) |
| 8 | D 2.7MM X 22MM (002-D-27022) |
| 9 | D 2.7MM X 24MM (002-D-27024) |
| 10 | D 2.7MM X 26MM (002-D-27026) |
| 11 | D 2.7MM X 28MM (002-D-27028) |
| 12 | D 2.7MM X 30MM (002-D-27030) |
| 13 | D 2.7MM X 32MM (002-D-27032) |
| 14 | D 2.7MM X 34MM (002-D-27034) |
| 15 | D 2.7MM X 36MM (002-D-27036) |
| 16 | D 2.7MM X 38MM (002-D-27038) |
| 17 | D 2.7MM X 40MM (002-D-27040) |
- Lot codes and dates
17 of 17 products
Products covered by this recall # Barcodes Product as published 1 8056099645782(8056099645782) B1075108 2 18056099645799(18056099645799) B1075105 3 18056099645805(18056099645805) B1071598, B1075178, B1075178 4 1805609964581218056099645812) B1069675, B1075431, B1075431 5 18056099645829(18056099645829) B1071545, B1075435 6 18056099645836(18056099645836) B1071540, B1075839 7 18056099645843(18056099645843) B1068567, B1075827, B1075827 8 18056099645850(18056099645850) B1082175, B1082175 9 18056099645867(18056099645867) B1082237, B1068549, B1082237 10 18056099645874(18056099645874) B1075060, B1082182 11 18056099645881(18056099645881) B1068574, B1082236 12 18056099645898(18056099645898) B1204990, B1071594, B1082232 13 18056099645904(18056099645904) B1204993, B1071543, B1082222 14 18056099645911(18056099645911) B1071542, B1195742, B1083645 15 18056099645928(18056099645928) B1071539, B1083644, B1195708, B1083644 16 18056099645935(18056099645935) B1204989, B1071541, B1089895 17 18056099645942(18056099645942) B1069679, B1195752, B1069679, B1082235 - Amount recalled
- 935
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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