Equinoxe 321-07-38Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10885862087171), received between Aug 19, 2020 and Aug 9, 2024 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE, THE SURGEON IMPACTED THE 38 HUMERAL LINER IMPACTOR TIP TO IMPACT THE 38 +0 HUMERAL LINER ONTO THE STEM. THE 38 HUMERAL LINER IMPACTOR TIP BROKE IN HALF. SURGERY CARRIED ON AS NORMAL. NO PARTS FELL INTO THE PATIENT WOUND SITE AND THE BROKEN TIP WAS REMOVED. THERE WERE NO SURGICAL DELAYS DURING THE PROCEDURE. THE DEVICE IS AVAILABLE FOR RETURN. AN IMAGE OF THE DEVICE WAS PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951095 ↗
• MalfunctionMay 9, 2024Break; Fracture; Break; Fracture

  AS REPORTED, THE HUMERAL STEM WAS IN THE ASSEMBLY TRAY DURING IMPACTION. THE HUMERAL LINER IMPACTOR TIP 38MM BROKE DURING THE IMPACTION OF THE 38 HUMERAL LINER. ALL FRAGMENTS, PARTS OR PIECES WERE REMOVED. THE SURGEON STATED THE HUMERAL LINER WAS NOT DAMAGED. SURGERY CARRIED ON AS NORMAL, THERE WAS NO DELAY. IMAGE RECEIVED. THE DEVICE WILL BE RETURN. NO PATIENT INFORMATION PROVIDED.

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

  MAUDE report 19281170 ↗
• InjuryNov 2, 2023Break; Break

  IT WAS REPORTED THAT THE IMPACTOR TIP SPLIT WHEN SURGEON IMPACTING THE LINER. THE MALE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO SURGICAL DELAY/PROLONGATION. DEVICE IS RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18059549 ↗
• InjuryApr 3, 2023Break; Break

  AS REPORTED, IMPACTOR TIP SNAPPED IN HALF DURING IMPACTION OF HUMERAL LINER. SURGERY WAS A REVISION OF A SHOULDER SPACER TO A REVERSE. HUMERAL COMPONENTS WERE BEING CEMENTED IN WITH HUMERAL LINER, HUMERAL TRAY AND STEM ALREADY ASSEMBLED. ON THE INITIAL IMPACTION THE STEM WAS STILL VERY PROUD AT THE TIME OF THE FIRST IMPACTION THE 38MM IMPACTOR TIP SNAPPED IN HALF. THERE WERE NO PIECES THAT FELL INTO PATIENT OR WOUND SITE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGE RECEIVED. THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO DEVICE WAS STUCK IN CEMENT SO HOSPITAL DISPOSED THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16671302 ↗
• MalfunctionDec 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGICAL USE, A 38MM IMPACTOR TIP FRACTURED DURING IMPACTION OF THE LINER. NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. THE PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15972623 ↗
• InjuryMay 25, 2022Break; Break

  IT WAS REPORTED THAT THE 38MM HUMERAL LINER IMPACTOR TIP SPLIT DURING IMPACTION OF THE LINER ONTO THE 0MM HUMERAL ADAPTER TRAY. NO DAMAGE TO 38MM +0MM HUMERAL LINER WAS NOTED AND IMPLANTATION WAS NOT AFFECTED. NO PARTS OR PIECES FELL INTO THE FEMALE PATIENT'S WOUND SITE. THERE WAS A SMALL SURGICAL DELAY, LESS THAN 5 MINUTES. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL BE RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498290 ↗
• 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 13825681 ↗
• MalfunctionAug 18, 2021Break; Break

  AS WAS REPORTED, THE SURGEON IMPACTED THE HUMERAL LINER WHEN THE BOTTOM OF THE 38MM HUMERAL LINER TIP FRACTURED OFF. THE BROKEN PIECE WAS THROWN AWAY BY CENTRAL STERILE AND WILL NOT RETURN. THERE WAS NO IMPACT ON THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340318 ↗
• MalfunctionApr 28, 2021Break; Break

  AS REPORTED, DURING A CASE ON THIS (B)(6) PATIENT, WHEN THE SURGEON WAS IMPACTING THE HUMERAL LINER, THE IMPACTOR TIP SNAPPED IN HALF AND FELL TO THE GROUND. NO PARTS OR PIECES FELL INTO THE WOUND. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11736819 ↗
• MalfunctionApr 14, 2021Break; Break

  AS REPORTED, THE IMPACTOR TIP CRACKED IN HALF UPON IMPACTION OF 38 HUMERAL LINER. THERE WERE NO PARTS OR PIECES LEFT IN THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE. PARTS RETURNED TO HEAD OFFICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE ISSUES DUE THE EVENT. DEVICE TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11663318 ↗
• MalfunctionMar 23, 2021Break; Break

  AS REPORTED, DURING A PROCEDURE ON THIS (B)(6) Y/O FEMALE PATIENT, THE IMPACTOR TIP BROKE INTO TWO PIECES WHILE IMPACTING A TRIAL. ALL PIECES WERE COLLECTED, AND NO HARM CAME TO THE PATIENT. THERE WAS LITTLE TO NO DELAY IN THE SURGERY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11552170 ↗
• MalfunctionFeb 26, 2021Naturally Worn; Naturally Worn

  AS REPORTED, DURING A PROCEDURE, THE PLASTIC BROKE IN TWO WHEN USED TO IMPACT LINER. IT WAS CONFIRMED THERE WERE NO PARTS AND PIECES THAT ENTERED THE PATIENT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PATIENT INFORMATION IS UNAVAILABLE. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11387212 ↗
• MalfunctionOct 14, 2020Break; Break

  AS REPORTED, DURING THE ASSEMBLY OF THE IMPLANT, THE IMPACTOR TIP SHATTERED WHEN THE SURGEON IMPACTED THE LINER ONTO THE TRAY. ITEM SHATTERED ON THE BACK TABLE. PATIENT WAS NOT INVOLVED WITH THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 10679248 ↗
• InjurySep 21, 2020Break; Break

  AS REPORTED, WHILST IMPACTING THE DEFINITIVE LINER IN FOR A SHOULDER REPLACEMENT, THE LINER IMPACTOR HEAD CRACKED INTO PIECES. ALL PIECES WERE REMOVED FROM THE PATIENT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PATIENT WAS NOT HARMED. DEVICE TO BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10559612 ↗
• MalfunctionAug 19, 2020Break; Break

  AS REPORTED, DURING A PROCEDURE, THE IMPACTOR TIP BROKE. THE TIP BROKE WHEN IT WAS IMPACTED. NO PIECES WERE LEFT IN THE PATIENT. THE SURGEON USED 38MM HUMERAL LINER IMPACTOR TIP TO PUT IN A 36MM HUMERAL LINER, AS THE 36MM IMPACTOR WAS NOT AVAILABLE. THE PATIENT WASN¿T AFFECTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THERE ARE FEWER SETS OF 36MM THAN 38 AND 42 AT THIS FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10424795 ↗

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-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-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-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-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-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.