Equinoxe 311-07-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885862084316), received between Nov 14, 2020 and Jul 30, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

10 other recalls cover devices cleared under the same FDA submission (K042021, K140063); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2021Break; Break

  AS REPORTED, DURING A PROCEDURE, THE IMPACTOR TIP BROKE OFF WHILE IMPACTING FINAL HUMERAL HEAD. NO PIECES LEFT IN PATIENT, NO DELAY TO SURGERY OR ADVERSE EFFECTS TO THE PATIENT. THE DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12251883 ↗
• MalfunctionJul 16, 2021Break; Break

  AS REPORTED, DURING THE PROCEDURE, THE IMPACTOR TIP BROKE OFF THE HANDLE WHILE IMPACTING HUMERAL HEAD. NOTHING FELL IN THE SURGICAL SITE, NO DELAY TO SURGERY, NO ADVERSE EFFECTS TO PATIENT. 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 12181996 ↗
• MalfunctionJun 9, 2021Break; Break

  AS REPORTED, THE SURGEON WAS USING THE INSTRUMENT IN AN ANATOMIC CASE ON THIS MALE PATIENT, HE USED A MALLET TO IMPACT THE HEAD ONTO THE STEM AND WHEN HE TOOK THE IMPACTOR HEAD AWAY FROM THE HEAD HE NOTICED IT HAS BROKEN AT THE JUNCTION OF THE IMPACTOR HEAD AND THE HANDLE. THE DEVICE WILL RETURN FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11964409 ↗
• MalfunctionNov 14, 2020Break; Break

  AS REPORTED, DURING A SHOULDER PROCEDURE ON A 30 Y/O MALE, THE FINAL STEM 13 + REPLICATOR 1.5 WERE MOUNTED TOGETHER ON A BACK TABLE ASSEMBLY. THE HUMERAL HEAD, SHORT, 47MM WAS IMPACTED AS WELL ON THE BACK TABLE. THIS CONSTRUCT WAS THEN IMPACTED IN THE HUMERUS, THE STEM WAS STUCK 2 CM HIGHER THAN THE CUT. DURING THE IMPACTION, THE HUMERAL HEAD IMPACTOR TIP WAS BROKEN. A FEMORAL HEAD IMPACTOR PRESENT IN THE HOSPITAL HAS BEEN CONSEQUENTLY USED TO GO ON THE SURGERY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE TO BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10841089 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042021, K140063. 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-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-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-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-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-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