MIZUHO ORTHOPEDIC SYSTEMS, INC. FDA Inspection Record
MIZUHO ORTHOPEDIC SYSTEMS, INC. is an FDA-registered facility (FEI 2921578) located in UNION CITY, CA, US. RegDataLab tracks 4 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Feb 25, 2016: No Action Indicated (NAI)
- Inspections on record
- 4 (2 VAI, 2 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
- 6, latest Jul 29, 2021
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 25, 2016 | No Action Indicated (NAI) | No citations listed |
| Sep 25, 2013 | Voluntary Action Indicated (VAI) | Evaluation, timeliness, identification (21 CFR 820.198(d)) |
| Sep 11, 2012 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Lack of or inadequate procedures (21 CFR 820.100(a)) Investigation of device failures (21 CFR 820.198(c)) Evaluation, timeliness, identification (21 CFR 820.198(d)) and 2 more |
| Jun 2, 2010 | No Action Indicated (NAI) | DHR content (21 CFR 820.184) Complaints (21 CFR 820.198(a)) Documentation of software validation (21 CFR 820.70(i)) Documentation (21 CFR 820.100(b)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 29, 2021 | Class II | Z-1573-2022 | HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144 One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number. |
| Feb 8, 2021 | Class II | Z-1293-2021 | Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 containing hand… There is a potential that hand control units may cause the tabletop to slide in the opposite direction from that selected by the user. This… |
| Oct 14, 2019 | Class II | Z-0091-2021 | Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI
Refurbished Levo Arm Label: LEVO ARM… Due to the potential for fluid ingress into the Arm which could affect the device's electrical system and lead to a failure of the locking… |
| Mar 28, 2017 | Class II | Z-1867-2017 | 216 Wilson Frame Pads, Model # 5319-37;
Used with Radiolucent Wilson Frames, model… Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may… |
| Dec 14, 2015 | Class II | Z-0792-2016 | Mizuho OSI Trios, Table Base;
Voltage: 100-240V ~ 50/60 Hz
Amps: 5,0-5.0A;
Model 7803… Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly. Over time, the parts could go out of… |
| Dec 17, 2012 | Class II | Z-0810-2013 | Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar. Possible instability of Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may migrate out of the carbon fiber tube. If this… |
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
- Mizuho OSI
- Location
- UNION CITY, CA (US)
- Source
- device