Equinoxe 321-09-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862557674), received between Oct 4, 2022 and Jan 9, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

2 FDA recall records name this device's identifier, 2 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 3, 2026Open, Classified

   Impactor handle may be missing cross-pin

   Z-1509-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. Jun 5, 2023Open, Classified

   The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

   Z-2051-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2024Break; Break

  AS REPORTED, DURING IMPACTION, THE BALL BEARING IS MISSING AND WILL NO LONGER HOLD IMPACTOR TIPS. THERE WERE NO FRAGMENTS OR PIECES THAT FELL INTO THE PATIENT. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN PHOTOS/X-RAYS. THE DEVICE WILL BE RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18476705 ↗
• InjuryMay 9, 2023Break; Break

  AS REPORTED, THE 78 Y/O MALE PATIENT RECEIVED A TOTAL SHOULDER REPLACEMENT. SURGEON NOTICED A BB AND SMALL SPRING ON PATIENT X-RAYS AND SENT THE IMAGES TO SALES REP. SALES REP RESEARCHED THE INSTRUMENTS AND NOTICED THE CATCH BUTTON MISSING ON THE MODULAR IMPACTOR HANDLE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGES RECEIVED. THE DEVICE IS AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE TIP BROKE DURING THE CASE, AND NO ONE NOTICED IT UNTIL AFTER SALES REP HAD ALREADY LEFT WITH THE CLEANED TRAYS. THE PATIENT IS OK, THE SURGEON STATES THAT HE AND THE PATIENT DECIDED TO LEAVE THE PIECES WHERE THEY ARE UNLESS THE PATIENT STARTS HAVING ISSUES. SURGEON CALLED SALES REP AND SAID HE WOULD KEEP WATCHING IT AS WELL, HE DOESN¿T EXPECT IT TO HURT OR IRRITATE ANYTHING. FURTHERMORE, THE DEVICE WAS USED LATER AT A DIFFERENT FACILITY AND NO ONE THERE NOTICED IT WAS BROKEN, BUT SOMEHOW THEY MADE IT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895059 ↗
• MalfunctionOct 4, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  DURING SURGICAL USE, WHEN THE BASEPLATE IMPACTOR TIP WAS REMOVED, A BEARING AND SECOND SMALL METAL PIECE FELL OUT OF THE END. ASSUMING THE CONSTRUCT OF THE HANDLE, IS A BEARING ON EACH END AND A METAL PIECE BETWEEN THEM, THE SECOND BEARING WAS NOT ACCOUNTED FOR. THE, PER DR PARSONS, CONCLUDED THAT IT WAS HIGHLY UNLIKELY THAT THE SECOND BEARING MADE IT INTO THE SURGICAL SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15537216 ↗