Equinoxe 321-07-42Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862087188), received between Feb 22, 2022 and Sep 18, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE IMPACTOR TIP BROKE WHEN IMPACTING FINAL IMPLANT ON BACK TABLE ASSEMBLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250031 ↗
• MalfunctionNov 30, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THIS SURGEON FIRSTLY USED 38MM IMPACTOR TIP ON 38 HUMERAL LINER BUT CRACKED AFTER FIRST HIT; UTILIZED SECOND 42MM IMPACTOR TIP, AFTER A COUPLE OF HITS IMPACTOR TIP WAS BROKEN OFF. NO PARTS OR PIECES FELL INTO THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236751 ↗
• MalfunctionApr 28, 2022Crack; Crack

  IT WAS REPORTED THAT SURGEON IMPACTED HUMERAL LINER, DEVICE DEVELOPED A CRACK. PART DIDN'T ACTUALLY BREAK, RATHER CRACKED, SO NO PIECES CAME LOOSE. NO PARTS FELL INTO THE(B)(6) PATIENT'S WOUND. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14237642 ↗
• InjuryMar 19, 2022Break; Break

  IT WAS REPORTED THAT DURING SURGICAL USE THE SURGEON IMPACTED THE POLY WHICH LED TO CRACKING OF THE 38 AND 42 IMPACTOR TIPS, THIS ALSO BENT THE IMPACTOR HANDLE. WHEN THE SURGEON WAS IMPACTING DEFINITIVE POLY INTO THE TRAY USING THE 38MM IMPACTOR TIP (321-07-38), THE TIP IMPACTOR FRACTURED. THE SURGEON IMPACTED WITH THE 42MM IMPACTOR TIP (321-07-42) AND THE IMPACTOR WAS FRACTURED AND THE HANDLE BENT (321-07-05). EVENT IS NOT ASSOCIATED WITH A REVISION OF EXACTECH IMPLANTS. PIECES HAD TO BE REMOVED FROM THE MALE PATIENT'S WOUND SITE. THERE WAS A 5-15 MIN SURGICAL DELAY, NO ADVERSE EVENTS DUE TO THIS PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13825734 ↗
• MalfunctionFeb 22, 2022Break; Break

  IT WAS REPORTED THAT DURING IMPACTION, THE RESIDENT IMPACTED THE HUMERAL LINER TRIAL INTO THE HUMERAL ADAPTER TRAY TO GET IT SEATED, UTILIZING A 42MM HUMERAL LINER IMPACTOR TIP. UPON IMPACTION, THE TOP OF THE IMPACTOR TIP FRACTED OFF. THERE WAS NO SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13581237 ↗

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-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-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-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-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-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.