Equinoxe 300-10-45 (UDI 10885862079398)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885862079398), received between Sep 3, 2019 and Oct 1, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

10 other recalls cover devices cleared under the same FDA submission (K042021); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  APPROXIMATELY 5 YEAR(S), 3 MONTH(S) AND 28 DAY(S) POST-OPERATIVE OF A RIGHT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. IT WAS FURTHER STATED THAT DISASSOCIATION OF OTHER COMPONENT - POSSIBLE SEPARATION OF POLY FROM BONE CAGE. APPROXIMATELY 9 MONTHS AND 21 DAYS AFTER THE INITIAL REPORT OF ISSUE, THE PATIENT UNDERWENT A STANDARD TOTAL REVISION WITH THE REMOVAL OF THE REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD, AND GLENOID. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20346437 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, APPROXIMATELY 9 MONTHS POST OP THE RIGHT REVERSE TOTAL SHOULDER ARTHROPLASTY OF THIS 69 Y/O MALE PATIENT WAS REVISED. THE PATIENT PRESENTED WITH GLENOID EROSION FROM A HEMI IN PLACE AND WAS REVISED TO EXACTECH REVERSE HUMERAL COMPONENTS AND OTHER MANUFACTURES GLENOID COMPONENTS. THERE WERE NO REPORTED ISSUES WITH THE REVISION PROCEDURE. THE PATIENT WAS DEEMED STABLE AFTER THE PROCEDURE. THE DEVISES WILL NOT BE RETURNED DUE TO HOSPITAL POLICY. NO ADDITIONAL INFORMATION.

  Patient problems: Erosion; Failure of Implant

  MAUDE report 16016670 ↗
• InjuryMar 16, 2021Mechanical Jam; Mechanical Jam

  AS REPORTED, WHILE TRIALING THE FINAL HUMERAL HEAD IN AN INITIAL LEFT TSA DURING THIS (B)(6) Y/O FEMALE, THE SURGEON REALIZED THE REPLICATOR PLATE WAS TILTED TOO FAR. HE WANTED TO UNSCREW THE TORQUE SCREW AND READJUST THE REPLICATOR PLATE ANGLE. THE SCREW WAS REMOVED, BUT WHEN THE REPLICATOR PLATE WAS TO BE REMOVED, IT TOOK OUT THE ENTIRE STEM. IT WAS A 14MM PRESERVE STEM THAT WAS ROTATIONALLY STABLE. AFTERWARDS, IN ATTEMPT TO REUSE THE SAME STEM, THE SURGEON TRIED TO REMOVE THE REPLICATOR PLATE ON THE BACK TABLE. THERE WAS NO WAY TO REMOVE THE REPLICATOR AFTER MULTIPLE ATTEMPTS, A VARIETY OF METHODS, AND AFTER MUCH SURGICAL TIME, THE REPLICATOR PLATE WAS DEEMED IRREMOVABLE AND ANOTHER 14MM STEM, TORQUE SCREW AND REPLICATOR PLATE HAD TO BE OPENED. THE PATIENT WAS NOT NEGATIVELY IMPACTED THAT WE KNOW OF, BUT PRODUCT WAS WASTED. NO KNOWN ADVERSE EVENTS AS A RESULT OF THE SURGICAL DELAY/PROLONGATION 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 11497020 ↗
• InjuryAug 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, APPROXIMATELY 2.5 YEARS POSTOP THE INITIAL TSA, THIS (B)(6) Y/O FEMALE PATIENT LOST RANGE OF MOTION IN HER RIGHT SHOULDER DUE TO HEMI-SHOULDER IMPLANT RIDING HIGH ON THE GLENOID. STEM RETAINED. CONVERTED TO SMALL BASEPLATE/36MM. NO DEVICES TO BE RETURNED, REMAIN IMPLANTED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

  Patient problems: Loss of Range of Motion

  MAUDE report 10430508 ↗
• InjurySep 3, 2019Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN. THE ORIGINAL TOTAL SHOULDER ARTHROPLASTY WAS PERFORMED ON THIS FEMALE PATIENT¿S RIGHT SHOULDER ON (B)(6) 2010. THE GLENOID COMPONENT HAD BEEN PREVIOUSLY REMOVED, AND THE PATIENT HAD A HEMI SHOULDER LEFT IN, SO THE PHYSICIAN WANTED TO REVISE TO AN RSA. THE PHYSICIAN EXPOSED THE HUMERAL COMPONENT, REMOVED THE HUMERAL HEAD AND REPLICATOR PLATE AND CHECKED STABILITY OF STEM. IT WAS WELL FIXED. HE THEN PROCEEDED TO THE GLENOID WHERE HE TOOK CULTURES, THEN IMPLANTED AN 8 DEGREE POSTERIOR BASEPLATE. HE FIXATED THE BASEPLATE WITH PERIPHERAL SCREWS AND TRIALED A 38MM GLENOSPHERE WITH A +0 TRAY AND +0 LINER FOR A 38MM GLENOSPHERE. ROM CHECKED AND DETERMINED THOSE TO BE THE CORRECT SIZES. THE PHYSICIAN THEN IMPLANTED A 38MM GLENOSPHERE WITH A +0MM HUMERAL TRAY AND +0MM POLY FOR A 38MM GLENOSPHERE. IT WAS ASSEMBLED IN SITU AND STABILITY WAS CHECKED AND DEEMED APPROPRIATE. THE PATIENT WAS STABLE AT THE END OF THE CASE AND IS EXPECTED TO HAVE A GOOD OUTCOME. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Pain

  MAUDE report 8955171 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021. 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-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-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-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-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-0884-2021 · Nov 9, 2020 · Open, Classified
  Equinoxe Humeral Stem, Primary, Press Fit, 11mm
• Z-1459-2015 · Feb 13, 2015 · Terminated
  Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
• Z-2115-2012 · Jun 15, 2012 · Terminated
  Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty