Equinoxe 321-45-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862232724), received between Apr 16, 2019 and Aug 7, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

13 other recalls cover devices cleared under the same FDA submission (K063569); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGERY WITH A 69 Y/O MALE PATIENT, THE TIP OF A REAMER BROKE AFTER HITTING A RETRACTOR WHILE REAMING. TIP WAS IMMEDIATELY FOUND AND REMOVED IN WHOLE. X RAY WAS REQUIRED TO PROVE NO PARTS REMAINED IN PATIENT. BREAKAGE CAUSED A SURGICAL DELAY/PROLONGATION BUT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING: HOSPITAL DISPOSED.

  Patient problems: Insufficient Information

  MAUDE report 19935481 ↗
• InjuryJun 30, 2024Break; Break

  IT WAS REPORTED DURING SURGERY THAT A 38MM PILOT TIP REAMER JAMMED AND THE PILOT TIP SNAPPED. ALL PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO SURGICAL DELAY. THE CASE PROCEEDED WITHOUT COMPLICATIONS AND A GOOD OUTCOME FOR THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGE RECEIVED. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19641000 ↗
• MalfunctionOct 1, 2021Break; Break

  AS REPORTED, THE SURGEON WAS REAMING AND THE TIP BROKE WHILE REAMING. THE TIP WAS NOT IN THE PATIENTS WOUND, CASE WAS NOT AFFECTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12563126 ↗
• MalfunctionDec 17, 2019Break; Break

  AS REPORTED, THE PILOT TIP BROKE OFF OF THE REAMER WHILE REAMING THE GLENOID, ALL PIECES WERE REMOVED FROM THE WOUND AND THE PATIENT WAS STABLE LEAVING THE OR. PICTURES OF THE DEVICE TO BE SENT. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9480210 ↗
• MalfunctionDec 13, 2019Break; Break

  AS REPORTED, A BOWTIE REAMER PILOT-TIP BROKE OFF WHILE ON THE MAYO STAND, OUTSIDE OF THE PATIENT. THE CAUSE OF THE BREAK WAS NOT OBVIOUS. THE PATIENT WAS UNAFFECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9465892 ↗
• MalfunctionApr 16, 2019Break; Difficult to Remove

  THE SURGEON WENT TO USE THE 38MM PILOT TIPPED BUTTERFLY REAMER ON THE TRI-DRIVE HANDLE AND JACOBS T-HANDLE AND LOCATED THE PILOT TIP IN THE PREVIOUSLY DRILLED HOLE. UPON TURNING THE REAMER A QUARTER OF A TURN, THE PILOT TIPPED SNAPPED OFF INSIDE THE GLENOID. THE SURGEON SPENT THE NEXT 45 MINUTES TRYING TO GET THE PILOT TIP OUT OF THE GLENOID BY TRYING VARIOUS METHODS BUT WAS UNABLE TO DO SO AND ENDED UP PUSHING IT FURTHER IN. IN THE END, HE ACCEPTED THAT HE WOULD HAVE TO LEAVE IT INSIDE THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8517679 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063569. One submission often covers many models, so check the product and lot details in each record.

• Z-2561-2025 · Aug 15, 2025 · Open, Classified
  Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/
• Z-1424-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
• Z-1419-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
• Z-1423-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
• Z-1422-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
• Z-1418-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
• Z-1425-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
• Z-0579-2024 · Nov 21, 2023 · Open, Classified
  Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00,
• Z-3019-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
• Z-3020-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
• Z-0012-2019 · Aug 21, 2018 · Open, Classified
  Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
• Z-0900-2017 · Oct 25, 2016 · Terminated
  Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
• Z-2117-2012 · Jun 15, 2012 · Terminated
  Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.