RegWardenFDA facility compliance records
Company

Corin Group

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

Recalls by year

FDA actions on record by year2021: 3 recalls; 2022: 4 recalls; 2023: 1 recalls2017201820192020320214202212023202420252026
  • Recalls (8)

Registered facilities (4)

Recalls & enforcement

  • Class IIOngoing2023-10-13
    Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
  • Class IIOngoing2022-11-08
    The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
  • Class IITerminated2022-10-31
    The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
  • Class IIOngoing2022-07-22
    One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
  • Class IITerminated2022-07-12
    Some of the devices did not pass fatigue testing.
  • Class IITerminated2021-07-28
    The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
  • Class IITerminated2021-05-06
    Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
  • Class IITerminated2021-01-25
    The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL and vice-versa.

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. “Corin Group — 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-9012268-corin-group/

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