Equinoxe 321-01-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862086846), received between Dec 28, 2020 and Dec 28, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 28, 2020Inadequacy of Device Shape and/or Size

  AS REPORTED, THE SURGEON WAS PERFORMING A RTSA. THE SELECTED TRIAL FOR THE STEM WAS A SIZE 13. WHEN IT WAS TIME FOR THE TRIALS, HE REDUCED THE SHOULDER AND THOUGHT IT WAS TOO TIGHT. HE DECIDED TO REDO THE HUMERAL CUT. HE PASSED THE REAMER, THEN THE BROACHES, THEN THE TRIAL STEM & THEN PERFORMED THE TRIALS ONCE AGAIN. HE AGAIN, THOUGHT IT WAS TOO TIGHT, HE WANTED TO REDO THE CUT AGAIN. THIS TIME HE ONLY PASSED THE REAMER SIZE 13. HE WANTED TO IMPLANT A FINAL STEM SIZE 13 ACCORDING TO FIRST TWO TRIALS PREVIOUSLY PERFORMED. HE FAILED TO CORRECTLY PLACE THE STEM AND IT WAS STUCK HIGHER THAN THE PLANNED CUT. THE SURGEON REMOVED THE SIZE 13 STEM AND USED A SIZE 11 STEM INSTEAD. THE SURGEON SUSPECTS THAT THE EXACTECH TRIAL SIZE 13 STEM DOES NOT MATCH WITH A 13 SIZE DEFINITIVE IMPLANT. THE SIZE 11 IMPLANT WAS ADEQUATE TO THE PATIENT. NO CONSEQUENCES FOR THE PATIENT. DEVICES TO BE RETURNED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11076063 ↗