Equinoxe 311-07-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885862084330), received between Oct 21, 2020 and Sep 9, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2024Fracture; Fracture

  IT WAS REPORTED FROM THE UK THAT DURING THE FIRST STAGES OF A CASE THE BLACK PLASTIC TIP BROKE OFF THE IMPACTOR TIP, FELL ONTO DRAPED TABLE. AREA COPIOUSLY IRRIGATED WITH CHLORHEXIDINE AS PER LOCAL POLICY. NO PARTS OR PIECES FELL INTO THE WOUND SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20176925 ↗
• MalfunctionJun 29, 2022Break; Break

  IT WAS REPORTED THAT THE DEVICE FRACTURED UPON IMPACTION OF THE HUMERAL HEAD. NO PARTS OR PIECES FELL INTO THE PATIENT WOUND SITE. THERE WAS NO SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO PATIENT INFORMATION/MEDICAL HISTORY AVAILABLE. DEVICE IS RETURNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14859960 ↗
• InjuryOct 21, 2020Break; Break

  AS REPORTED, DURING A SHOULDER PROCEDURE FOR THIS (B)(6) Y/O MALE PATIENT, DURING THE FINAL IMPACTION OF THE HUMERAL HEAD BY THE SURGEON, PART OF THE IMPACTION TIP BROKE OFF. AS THE HEAD HAD ALREADY BEEN IMPACTED SUFFICIENTLY NO FURTHER IMPACTION WAS REQUIRED. THE BROKEN PART WAS RETRIEVED AND SENT TO CSSD ALONG WITH THE REST OF THE INSTRUMENTS. ONE LARGE PIECE BROKE OFF, SO IT WAS EASY FOR THE SURGEON TO REMOVE. UNFORTUNATELY, THE BROKEN PART DID NOT MATERIALIZE AFTER DECONTAMINATION AND THEREFORE HAS NOT BEEN RETURNED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE TO BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10711069 ↗

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-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-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-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-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-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-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