RegWardenFDA facility compliance records
Company

Ortho Development Corporation

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

Recalls by year

FDA actions on record by year2014: 2 recalls; 2019: 1 recalls2’14’15’16’17’181’19’20’21’22’23’24’25’26
  • Recalls (3)

Registered facilities (1)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Ortho Development Corporation — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9012515-ortho-development-corporation/

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