ORTHOFIX SRL FDA Inspection Record
ORTHOFIX SRL is an FDA-registered facility (FEI 3002807827) located in BUSSOLENGO Verona, IT. RegDataLab tracks 1 FDA inspection at this facility.
What FDA found at this site
- Latest inspection
- Sep 27, 2012: Voluntary Action Indicated (VAI)
- Inspections on record
- 1 (1 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 4, latest Sep 24, 2024
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 27, 2012 | Voluntary Action Indicated (VAI) | Design validation- Lack of or inadequate procedures (21 CFR 820.30(g)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Sep 24, 2024 | Class II | Z-1977-2025 | REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend at the distal tail during insertion… |
| Sep 27, 2018 | Class II | Z-0373-2020 | ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY… and 30 more products As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to… |
| Jan 30, 2018 | Class II | Z-2063-2018 | TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM… The firm received complaints regarding the incompatibility and dimensional interference between the double row footplates manufactured in a… |
| Jul 5, 2017 | Class II | Z-0291-2018 | Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and… The power drill torque limiter may break during use in surgery application. |
FDA record score
5 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
6 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall Z-1977-2025, this FEI as the recalling firm | Sep 24, 2024 | 4 x 0.6 | 2.4 |
| Class II recall Z-0373-2020, this FEI as the recalling firm | Sep 27, 2018 | 4 x 0.25 | 1 |
| Class II recall Z-2063-2018, this FEI as the recalling firm | Jan 30, 2018 | 4 x 0.25 | 1 |
| Class II recall Z-0291-2018, this FEI as the recalling firm | Jul 5, 2017 | 4 x 0.25 | 1 |
| Inspection classified VAI | Sep 27, 2012 | 10 years or older, so it adds no points | 0 |
| 45 import refusals in 2011 | Dec 31, 2011 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 15, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
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Facility details
- Company
- Orthofix Srl
- Location
- BUSSOLENGO Verona (IT)
- Source
- device