Equinoxe 321-25-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10885862087614), received between Sep 23, 2019 and Aug 10, 2023 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (9 reports).

18 other recalls cover devices cleared under the same FDA submission (K042021, K093430, K113309); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2023Break; Break

  IT WAS REPORTED THAT DURING SURGICAL USE THE PIN TIP ON THE PILOT TIPPED STARTER REAMER (321-25-01) BROKE OFF THE REAMER AND ENDED UP IN THE PATIENTS WOUND. THE SURGEON FINISHED THE PROCEDURE AND BEFORE CLOSING USED X-RAY TO LOCATE THE BROKEN PIECE AND REMOVE IT PRIOR TO CLOSING THE WOUND. THE SURGEON ADMITTED THAT HE MAY HAVE CONTRIBUTED TO THE INSTRUMENT BREAKING BY LEANING ON IT TOO HARD WHEN REAMING. THERE WAS ABOUT A 10MIN DELAY TO THE PROCEDURE WHILE LOCATING AND EXTRACTING THE BROKEN TIP. NO PATIENT INFORMATION AVAILABLE. NO PHOTOS OR X-RAYS PROVIDED. PRODUCT IS RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17500223 ↗
• MalfunctionApr 12, 2023Break; Break

  IT WAS REPORTED THAT THE REAM AND THE MECHANISM AT THE BOTTOM WHERE IT CONNECTS BECAME LOOSE AND STOPPED WORKING PROPERLY. IT DID NOT IMPACTED THE CASE OUTCOMES AND PIECES DID NOT FALL IN TO THE WOUND SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723177 ↗
• InjuryOct 22, 2021Break; Break

  AS REPORTED, WHILE REAMING THE GLENOID WITH THE REVERSE PILOT STARTER REAMER, THE PILOT TIP PORTION OF THE REAMER BROKE OFF IN THE MALE PATIENT¿S GLENOID. A MIDAS WAS USED TO BUR OUT A PORTION, HOWEVER, THE PIECE SEEMED TO GO DEEPER INTO GLENOID AND SURGEON IS UNSURE THE ENTIRE PIECE WAS REMOVED, A PORTION IS BELIEVED TO BE LEFT IN PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE IS TO BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681544 ↗
• InjuryJul 15, 2021Break; Break

  DURING A PROCEDURE ON THIS (B)(6) Y/O MALE, AS THE SURGEON STARTED TO REAM WITH THE STARTER PILOT TIP REAMER, THE TIP BROKE AWAY. IT WAS SUCTIONED OUT OF THE PATIENT AND UNRECOVERABLE. C ARM X-RAY CONFIRMED THE TIP WAS NO LONGER IN THE PATIENT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. MINOR INCONVENIENCE, NO PATIENT ISSUES DUE TO INSTRUMENT BREAKAGE. THE DEVICE (WITHOUT THE TIP) WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172460 ↗
• MalfunctionApr 9, 2021Break; Break

  AS REPORTED, THE TIP OF THE REAMER BROKE OFF AFTER FIRST INITIAL REAM. PATIENT NOT AFFECTED, NO DELAY, AND NO ISSUES MOVING FORWARD IN SURGERY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11640127 ↗
• InjuryJan 20, 2021Break; Break

  AS REPORTED, THE TIP OF A REAMER BROKE OFF WHILE REAMING THE GLENOID ON THIS MALE PATIENT. THE TIP WAS EASILY RETRIEVED, AND AN X RAY WAS TAKEN TO PROVE NO PARTS WERE LEFT IN THE PATIENT. NO HARM WAS DONE TO THE PATIENT AND IT ADDED NO TIME TO THE OPERATION. THE DEVICE WILL RETURN FOR EVALUATION. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11200791 ↗
• InjuryJul 17, 2020Break; Break

  DURING THE PROCEDURE, WHILE COMPLETING THE INITIAL REAMING OFF AXIS REAMING, THE PILOT TIP BROKE OFF COMPLETELY. ANY PIECES WERE REMOVED FROM THE PATIENT. NO PROBLEMS WERE CAUSED, AND THE CASE WAS COMPLETED WITHOUT INCIDENT. THE PATIENT WAS VERY SMALL PATIENT WITH DIFFICULT EXPOSURE. THE DEVICE IS RETURNING, AND NO PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10288268 ↗
• MalfunctionSep 23, 2019Break

  IT AS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY GETTING THE REAMER IN DUE TO PATIENT ANATOMY. THE TIPS BROKE OFF OF EACH OF THESE REAMERS. THE TIPS DID NOT REMAIN IN THE PATIENT AND WERE REMOVED BEFORE PROCEEDING. THE PATIENT WAS STABLE UPON LEAVING THE OPERATING ROOM.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9104366 ↗
• MalfunctionSep 23, 2019Break; Difficult to Insert; Detachment of Device or Device Component

  IT AS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY GETTING THE REAMER IN DUE TO PATIENT ANATOMY. THE TIPS BROKE OFF OF EACH OF THESE REAMERS. THE TIPS DID NOT REMAIN IN THE PATIENT AND WERE REMOVED BEFORE PROCEEDING. THE PATIENT WAS STABLE UPON LEAVING THE OPERATING ROOM.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9104230 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021, K093430, K113309. One submission often covers many models, so check the product and lot details in each record.

• Z-0535-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: N
• Z-0536-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: N
• Z-0537-2026 · Sep 5, 2025 · Open, Classified
  Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Compo
• Z-1412-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 3
• Z-1413-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47
• Z-1415-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Numbe
• Z-1403-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Nu
• Z-1402-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item
• Z-1414-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number
• Z-1404-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Nu
• Z-1405-2024 · Mar 6, 2024 · Open, Classified
  Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02
• Z-0884-2021 · Nov 9, 2020 · Open, Classified
  Equinoxe Humeral Stem, Primary, Press Fit, 11mm
• Z-0459-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
• Z-0460-2021 · Oct 6, 2020 · Terminated
  Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
• Z-0415-2018 · Aug 31, 2017 · Terminated
  Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of

…and 3 more.