Facility

ORTHO DEVELOPMENT CORP.

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

Key facts

3recalls · worst Class II

2inspections · worst NAI

—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)	1000143502
Establishment type	Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	12187 SOUTH BUSINESS PARK DR. DRAPER, UT, US 84020
Registration status	Active · expires 2026
Parent company	Ortho Development Corporation (owner-operator 9012515)
Brand names	Contour Spinal System

Activity by year

Recalls (3)
Inspections (2)

Devices registered here (2)

Appliance, Fixation, Spinal Interlaminal
Product code KWP (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3050
Orthosis, Spondylolisthesis Spinal Fixation
Product code MNH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3070

Recalls & enforcement

Class IIOngoing2019-05-30
The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled.
Class IITerminated2014-07-11
Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties …
Class IITerminated2014-04-01
A femoral component containing pegs was found in a box for the pegless version.

FDA inspections (2)

NAI2021-07-19
No Action Indicated · Compliance: Devices
NAI2016-10-04
No 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.

All facilities operated by Ortho Development Corporation

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. “ORTHO DEVELOPMENT CORP. (FEI 1000143502) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000143502-ortho-development-corp/

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