RegWardenFDA facility compliance records
Facility

UNITED ORTHOPEDIC CORP.

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

Activity by year

FDA actions on record by year2017: 2 recalls; 2024: 1 recalls; 2026: 2 recalls, 1 inspections2201720182019202020212022202312024202532026
  • Recalls (5)
  • Inspections (1)

Devices registered here (1)

  • Appliance, Fixation, Spinal Intervertebral Body
    Product code KWQ (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3060

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.

FDA inspections (1)

  • VAI2026-03-12
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

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 CORP. (FEI 1000395711) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000395711-united-orthopedic-corp/

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