Equinoxe 320-20-34Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862086563), received between Apr 3, 2019 and Sep 19, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2023Fracture; Fracture

  AS REPORTED, DURING AN INITIAL IMPLANT SURGERY, THE SURGEON WAS PUTTING THE SCREWS IN THE BASEPLATE AND WHEN HE TORQUED ON THE 4.5 X 38 SCREW, THE TOP OF THE SCREW BROKE OFF. HE THOUGHT IT WAS DUE TO THE VERY HARD BONE AND GRIP HE WAS ABLE TO GET WITH THE THREADS. BECAUSE IT WAS JUST THE HEAD THAT BROKE OFF AND ALL OF THE OTHER SCREWS WERE DOWN AND WELL FIXED, HE LEFT THE BROKEN PORTION OF THE SCREW IN PLACE. HE DID ADD ANOTHER SCREW SO THAT HE HAD 3 SCREWS HOLDING DOWN THE BASEPLATE. HE ALSO DECIDED TO PUT THE LOCKING CAP OVER THE SCREW THAT HAD THE HEAD BREAK OFF. NO FRAGMENTS, PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE, ALL WERE REMOVED. THERE WAS NO REPORTED SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778218 ↗
• InjuryFeb 2, 2022Break; Break

  AS REPORTED, THIS (B)(6) MALE PATIENT'S LEFT SHOULDER WAS REVISED DUE TO THE BASEPLATE SCREWS BREAKING. THE BASEPLATE, GLENOSPHERE, TRAY, AND LINER WERE REVISED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 13423460 ↗
• InjuryFeb 2, 2022Break; Break

  AS REPORTED, THIS (B)(6) Y/O MALE PATIENT'S LEFT SHOULDER WAS REVISED DUE TO THE BASEPLATE SCREWS BREAKING. THE BASEPLATE, GLENOSPHERE, TRAY, AND LINER WERE REVISED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING DUE TO HOSPITAL POLICY.

  Patient problems: Failure of Implant

  MAUDE report 13423459 ↗
• InjuryApr 3, 2019Loosening of Implant Not Related to Bone-Ingrowth

  REVISION DUE TO INFECTION. IT WAS INFECTED AND LOOSE.

  Patient problems: Unspecified Infection

  MAUDE report 8477619 ↗
• InjuryApr 3, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION DUE TO INFECTION. IT WAS INFECTED AND LOOSE.

  Patient problems: Unspecified Infection

  MAUDE report 8477604 ↗

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-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-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-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-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-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-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-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-3020-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
• Z-3019-2020 · Aug 24, 2020 · Terminated
  Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 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.