Facility

UNITED ORTHOPEDIC CORPORATION

5 recall(s) on record — most severe on record: Class II.

Key facts

5recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3012329926
Establishment type	Export Device to the United States But Perform No Other Operation on Device; Manufacture Medical Device
Location	57 Park Ave. 2, Science Park Hsinchu Hsinchu(County), TW TW NOTA300
Registration status	Active · expires 2026
Parent company	UNITED ORTHOPEDIC CORPORATION (owner-operator 9025838)
Brand names	EQUATION FIXATION SYSTEM

Activity by year

Recalls (5)

Devices registered here (2)

Orthosis, Spinal Pedicle Fixation
Product code MNI (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3070
Orthosis, Spondylolisthesis Spinal Fixation
Product code MNH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3070

Recalls & enforcement

Class IIOngoing2026-05-20
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Class IIOngoing2026-03-19
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Class IIOngoing2024-01-03
Their is a potential that the implant curved stem may be oriented incorrectly.
Class IITerminated2017-11-24
UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.
Class IITerminated2017-02-10
The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “UNITED ORTHOPEDIC CORPORATION (FEI 3012329926) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012329926-united-orthopedic-corporation/

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