ULRICH MEDICAL USA, INC. FDA Inspection Record
ULRICH MEDICAL USA, INC. is an FDA-registered facility (FEI 3005532635) located in Plano, TX, US. RegDataLab tracks 4 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Mar 17, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 4 (3 VAI, 1 NAI)
- 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
- 2, latest Dec 31, 2019
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 17, 2025 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) |
| Mar 6, 2019 | Voluntary Action Indicated (VAI) | No citations listed |
| Jan 12, 2017 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 25, 2010 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Dec 31, 2019 | Class II | Z-1350-2020 | Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for… Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque… |
| Mar 8, 2019 | Class II | Z-1126-2019 | ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final… Certain Torque Limiting Handles in the field are beyond their 3 year calibration life. |
FDA record score
11 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.
5 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Mar 17, 2025 | 6 x 1 | 6 |
| Inspection classified VAI | Mar 6, 2019 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Jan 12, 2017 | 6 x 0.25 | 1.5 |
| Class II recall Z-1350-2020, this FEI as the recalling firm | Dec 31, 2019 | 4 x 0.25 | 1 |
| Class II recall Z-1126-2019, this FEI as the recalling firm | Mar 8, 2019 | 4 x 0.25 | 1 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 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 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- Ulrich Medical USA Inc
- Location
- Plano, TX (US)
- Source
- device